5,095 Quality Assurance Auditor jobs in the United States
Quality Assurance Auditor
Posted today
Job Viewed
Job Description
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Job Summary:
The primary responsibility of a QA Lot Review Specialist IV is the closeout of all documentation prior to the release of Production Batches. QA Lot Review Specialist IV is responsible for the coordination of documentation as well as all meetings to discuss release deliverables and guiding junior QA Specialist staff on review priorities for documentation. Documentation includes manufacturing batch records and ancillary documentation such as Lot Genealogy Reports, Quality Control Assays used in the production of Active Pharmaceutical Ingredients (API) at the Lonza Portsmouth Facility. Quality Assurance Lot Review Specialist IV makes decisions regarding simple and complex issues that arise during review of records and assists junior staff with decision making. Escalation to senior members of the QA Operations team is employed for minimal issues. QA Lot Review Specialist IV demonstrates understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, Regulatory expectations, as well as pro fessional skills of effective leadership, communication and listening. Regularly demonstrates leadership skills such as coaching, training and mentoring staff with regards to regulatory and Lonza expectations. Leads Process improvement team assignments. So me External Customer interaction may be required
This position requires full time presence at our Portsmouth, NH location.
Key Responsibilities:
Independent review and closure of manufacturing batch records.
Process knowledge is used to address complex issues with minimal management input and to assist junior levels with similar issues.
Ensures all events are investigated as required. The Specialist can identify all non- conformances (simple and complex), understands the GMP implications of the nonconformance, and knows what actions to take with minimal guidance from their management.
Participation in daily lot release meeting and other routine meetings as assigned by management.
Trains staff as required and guides junior QA specialists on review priorities.
Demonstrates skills that include understanding of quality systems, basic biologics manufacturing, Good Documentation practices, communication and listening.
Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
Supports daily management systems.
Perform other duties as assigned.
Key Requirements:
Bachelor’s Degree in Life Science. A combination of education and years of experience will be considered
5-10 years in a cGMP Environment
Knowledge of Microsoft Office Tools (Word, Excel, Outlook) is required; knowledge of cGMP preferred (ICH Q7a, CFR 210/211 CFR 820 etc.)
Attention to detail and critical thinking skills are required; knowledge of Trackwise, SAP are preferred
Excellent written and verbal communicator at all levels. Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint) preferred
Motivated self - starter who has high attention to detail and adoptable to changing priorities and reprioritization of workload
Works effectively individually and within a team environment with direction as required
Presents facts clearly and logically and understands other perspectives
Able to identify and act on situations that require escalation with / without guidance
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Quality Assurance Auditor
Posted today
Job Viewed
Job Description
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Job Summary:
The primary responsibility of a QA Lot Review Specialist IV is the closeout of all documentation prior to the release of Production Batches. QA Lot Review Specialist IV is responsible for the coordination of documentation as well as all meetings to discuss release deliverables and guiding junior QA Specialist staff on review priorities for documentation. Documentation includes manufacturing batch records and ancillary documentation such as Lot Genealogy Reports, Quality Control Assays used in the production of Active Pharmaceutical Ingredients (API) at the Lonza Portsmouth Facility. Quality Assurance Lot Review Specialist IV makes decisions regarding simple and complex issues that arise during review of records and assists junior staff with decision making. Escalation to senior members of the QA Operations team is employed for minimal issues. QA Lot Review Specialist IV demonstrates understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, Regulatory expectations, as well as pro fessional skills of effective leadership, communication and listening. Regularly demonstrates leadership skills such as coaching, training and mentoring staff with regards to regulatory and Lonza expectations. Leads Process improvement team assignments. So me External Customer interaction may be required
This position requires full time presence at our Portsmouth, NH location.
Key Responsibilities:
Independent review and closure of manufacturing batch records.
Process knowledge is used to address complex issues with minimal management input and to assist junior levels with similar issues.
Ensures all events are investigated as required. The Specialist can identify all non- conformances (simple and complex), understands the GMP implications of the nonconformance, and knows what actions to take with minimal guidance from their management.
Participation in daily lot release meeting and other routine meetings as assigned by management.
Trains staff as required and guides junior QA specialists on review priorities.
Demonstrates skills that include understanding of quality systems, basic biologics manufacturing, Good Documentation practices, communication and listening.
Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
Supports daily management systems.
Perform other duties as assigned.
Key Requirements:
Bachelor’s Degree in Life Science. A combination of education and years of experience will be considered
5-10 years in a cGMP Environment
Knowledge of Microsoft Office Tools (Word, Excel, Outlook) is required; knowledge of cGMP preferred (ICH Q7a, CFR 210/211 CFR 820 etc.)
Attention to detail and critical thinking skills are required; knowledge of Trackwise, SAP are preferred
Excellent written and verbal communicator at all levels. Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint) preferred
Motivated self - starter who has high attention to detail and adoptable to changing priorities and reprioritization of workload
Works effectively individually and within a team environment with direction as required
Presents facts clearly and logically and understands other perspectives
Able to identify and act on situations that require escalation with / without guidance
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Quality Assurance Auditor
Posted today
Job Viewed
Job Description
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Job Summary:
The primary responsibility of a QA Lot Review Specialist IV is the closeout of all documentation prior to the release of Production Batches. QA Lot Review Specialist IV is responsible for the coordination of documentation as well as all meetings to discuss release deliverables and guiding junior QA Specialist staff on review priorities for documentation. Documentation includes manufacturing batch records and ancillary documentation such as Lot Genealogy Reports, Quality Control Assays used in the production of Active Pharmaceutical Ingredients (API) at the Lonza Portsmouth Facility. Quality Assurance Lot Review Specialist IV makes decisions regarding simple and complex issues that arise during review of records and assists junior staff with decision making. Escalation to senior members of the QA Operations team is employed for minimal issues. QA Lot Review Specialist IV demonstrates understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, Regulatory expectations, as well as pro fessional skills of effective leadership, communication and listening. Regularly demonstrates leadership skills such as coaching, training and mentoring staff with regards to regulatory and Lonza expectations. Leads Process improvement team assignments. So me External Customer interaction may be required
This position requires full time presence at our Portsmouth, NH location.
Key Responsibilities:
Independent review and closure of manufacturing batch records.
Process knowledge is used to address complex issues with minimal management input and to assist junior levels with similar issues.
Ensures all events are investigated as required. The Specialist can identify all non- conformances (simple and complex), understands the GMP implications of the nonconformance, and knows what actions to take with minimal guidance from their management.
Participation in daily lot release meeting and other routine meetings as assigned by management.
Trains staff as required and guides junior QA specialists on review priorities.
Demonstrates skills that include understanding of quality systems, basic biologics manufacturing, Good Documentation practices, communication and listening.
Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
Supports daily management systems.
Perform other duties as assigned.
Key Requirements:
Bachelor’s Degree in Life Science. A combination of education and years of experience will be considered
5-10 years in a cGMP Environment
Knowledge of Microsoft Office Tools (Word, Excel, Outlook) is required; knowledge of cGMP preferred (ICH Q7a, CFR 210/211 CFR 820 etc.)
Attention to detail and critical thinking skills are required; knowledge of Trackwise, SAP are preferred
Excellent written and verbal communicator at all levels. Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint) preferred
Motivated self - starter who has high attention to detail and adoptable to changing priorities and reprioritization of workload
Works effectively individually and within a team environment with direction as required
Presents facts clearly and logically and understands other perspectives
Able to identify and act on situations that require escalation with / without guidance
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Quality Assurance Auditor
Posted today
Job Viewed
Job Description
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Job Summary:
The primary responsibility of a QA Lot Review Specialist IV is the closeout of all documentation prior to the release of Production Batches. QA Lot Review Specialist IV is responsible for the coordination of documentation as well as all meetings to discuss release deliverables and guiding junior QA Specialist staff on review priorities for documentation. Documentation includes manufacturing batch records and ancillary documentation such as Lot Genealogy Reports, Quality Control Assays used in the production of Active Pharmaceutical Ingredients (API) at the Lonza Portsmouth Facility. Quality Assurance Lot Review Specialist IV makes decisions regarding simple and complex issues that arise during review of records and assists junior staff with decision making. Escalation to senior members of the QA Operations team is employed for minimal issues. QA Lot Review Specialist IV demonstrates understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, Regulatory expectations, as well as pro fessional skills of effective leadership, communication and listening. Regularly demonstrates leadership skills such as coaching, training and mentoring staff with regards to regulatory and Lonza expectations. Leads Process improvement team assignments. So me External Customer interaction may be required
This position requires full time presence at our Portsmouth, NH location.
Key Responsibilities:
Independent review and closure of manufacturing batch records.
Process knowledge is used to address complex issues with minimal management input and to assist junior levels with similar issues.
Ensures all events are investigated as required. The Specialist can identify all non- conformances (simple and complex), understands the GMP implications of the nonconformance, and knows what actions to take with minimal guidance from their management.
Participation in daily lot release meeting and other routine meetings as assigned by management.
Trains staff as required and guides junior QA specialists on review priorities.
Demonstrates skills that include understanding of quality systems, basic biologics manufacturing, Good Documentation practices, communication and listening.
Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
Supports daily management systems.
Perform other duties as assigned.
Key Requirements:
Bachelor’s Degree in Life Science. A combination of education and years of experience will be considered
5-10 years in a cGMP Environment
Knowledge of Microsoft Office Tools (Word, Excel, Outlook) is required; knowledge of cGMP preferred (ICH Q7a, CFR 210/211 CFR 820 etc.)
Attention to detail and critical thinking skills are required; knowledge of Trackwise, SAP are preferred
Excellent written and verbal communicator at all levels. Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint) preferred
Motivated self - starter who has high attention to detail and adoptable to changing priorities and reprioritization of workload
Works effectively individually and within a team environment with direction as required
Presents facts clearly and logically and understands other perspectives
Able to identify and act on situations that require escalation with / without guidance
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Quality Assurance Auditor
Posted today
Job Viewed
Job Description
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want you to be part of.
Job Summary:
The Head of Quality Control (QC) is responsible for Quality Control activities including biochemistry, microbiology, environmental monitoring, raw materials, stability, method transfer, instrument and software qualification, data integrity, sample management, and QC document management.
The Head of QC provides a safe, controlled work environment in all areas of responsibility while being aware of the site safety objectives and making sure these are communicated and understood by all staff. Provides guidance to supervisors and other frontline leads to achieve goals in accordance with established policies. Establishes and recommends changes to policies which affect subordinate organizations. Develops and administers budgets, schedules and performance requirements.
Role will be responsible for Championing operational excellence and innovation as well QC financial targets, to ensure stable planning of QC activities as per site needs. Responsible for people development and growth. Creates a culture in the QC organization that leads to employee satisfaction and retention. Contributes to the site’s growth strategy, including planning, budgeting, and safety .
Key Responsibilities:
Partners with the Site Quality Head, Site Leadership Team, and Global Quality functions in executing the strategic goals of the company
Lead the Quality Control Department for the Mammalian Business Unit at Lonza Portsmouth with responsibility for the following groups within the department: Raw Material, Analytical, Biochemistry, Microbiology, Environmental Monitoring, Assay validation/transfer, laboratory information and sample logistics and includes all personnel associated with the department i.e. FTE, interns and contractors
Develops and executes the QC strategy for the site. Ensures quality and delivery meets or exceeds internal stakeholder and customer expectations
Ov ersees raw materials testing, in-process and finished product testing, environmental monitoring and microbiology, stability testing, method transfer and validation, instrument and software qualification, QC data integrity, sample management, and QC document management
Drives continuous improvement initiatives to ensure that the QC organization meets key performance indicator goals
To evaluate and prioritize QC projects in the medium and long term, ensuring that the human, technical and financial resources are focused on the achievement of strategic objectives
Works closely with Program Management, Quality Assurance, Manufacturing Asset leadership, and customers to support project teams throughout the product lifecycle
Attends Site Quality Council (monthly) and other meetings as needed, e.g. Change Control Committee, Deviation Review Board, CAPA Board
Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance in resolving issues
Builds and maintains expertise in the QC organization, ensuring that the QC organization supports site operations through ongoing development of staff
Represents QC function in Joint Steering Committee meetings with customers
Supports Regulatory and Customer Audits as needed
Manages the QC budget process
Responsible for providing support to the QC Department of the Cell & Gene Therapies Business Unit for certain shared services including Raw Materials, QC Systems, Sample Logistics etc.
To approve or reject starting materials, packaging materials, intermediate, bulk and finished products
Responsible to ensure the QC operations comply to cGMP and safety regulations
Responsible to ensure QC participation in the multidisciplinary customer teams (IPT, JPT) and the global QC work teams
To lead the development and implementation of improvement systems in the area in line with the Operational Excellence strategy
Ensure escalation of non-compliance or ineffective Quality System deployment at site
Plan resources for QC to support projects and testing in alignment with production activities. To ensure that all necessary testing is carried out and the associated records evaluated
To lead the method transfer activities for customer projects in Quality Control
To lead from a QC standpoint audits/inspections by customers and/or regulatory agencies
To ensure the development and coaching of QC staff in order to improve their performance, abilities and competences
Drive the timely release of test results and approval of certificate of Analysis to support batch release
Ensure that product has been manufactured and tested in accordance with c GMP requirements, company SOPs, policies and specifications
To approve specifications, sampling instructions, test methods and other Quality Control procedures.
To ensure the qualification and maintenance of QC premises / equipment and appropriate validations are done
Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures
Any other duties as assigned by Site Quality Head
Key Requirements:
Bachelor's degree in Life Sciences is preferred; a combination of education and years of experience will be considered w ith 10+ years of QC experience
Proven experience in leadership positions
Leadership skills- ability to coach, manage and lead diverse teams
Demonstrated ability to present ideas publicly to inform, educate and influence others positively in achieving business results
Excellent communications skills both written and verbal format
Relate to others in a team setting. Active listener seeking to understand and to be understood. Able to coach and manage experienced and inexperienced staff
Maintain positive attitude and emotional composure in a team environment
Maintain control of meetings with direct reports
Mentoring and leading direct reports
Being able to deliver difficult messages to staff (i.e. disciplinary actions, poor performance plans)
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Quality Assurance Auditor
Posted today
Job Viewed
Job Description
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want you to be part of.
Job Summary:
The Head of Quality Control (QC) is responsible for Quality Control activities including biochemistry, microbiology, environmental monitoring, raw materials, stability, method transfer, instrument and software qualification, data integrity, sample management, and QC document management.
The Head of QC provides a safe, controlled work environment in all areas of responsibility while being aware of the site safety objectives and making sure these are communicated and understood by all staff. Provides guidance to supervisors and other frontline leads to achieve goals in accordance with established policies. Establishes and recommends changes to policies which affect subordinate organizations. Develops and administers budgets, schedules and performance requirements.
Role will be responsible for Championing operational excellence and innovation as well QC financial targets, to ensure stable planning of QC activities as per site needs. Responsible for people development and growth. Creates a culture in the QC organization that leads to employee satisfaction and retention. Contributes to the site’s growth strategy, including planning, budgeting, and safety .
Key Responsibilities:
Partners with the Site Quality Head, Site Leadership Team, and Global Quality functions in executing the strategic goals of the company
Lead the Quality Control Department for the Mammalian Business Unit at Lonza Portsmouth with responsibility for the following groups within the department: Raw Material, Analytical, Biochemistry, Microbiology, Environmental Monitoring, Assay validation/transfer, laboratory information and sample logistics and includes all personnel associated with the department i.e. FTE, interns and contractors
Develops and executes the QC strategy for the site. Ensures quality and delivery meets or exceeds internal stakeholder and customer expectations
Ov ersees raw materials testing, in-process and finished product testing, environmental monitoring and microbiology, stability testing, method transfer and validation, instrument and software qualification, QC data integrity, sample management, and QC document management
Drives continuous improvement initiatives to ensure that the QC organization meets key performance indicator goals
To evaluate and prioritize QC projects in the medium and long term, ensuring that the human, technical and financial resources are focused on the achievement of strategic objectives
Works closely with Program Management, Quality Assurance, Manufacturing Asset leadership, and customers to support project teams throughout the product lifecycle
Attends Site Quality Council (monthly) and other meetings as needed, e.g. Change Control Committee, Deviation Review Board, CAPA Board
Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance in resolving issues
Builds and maintains expertise in the QC organization, ensuring that the QC organization supports site operations through ongoing development of staff
Represents QC function in Joint Steering Committee meetings with customers
Supports Regulatory and Customer Audits as needed
Manages the QC budget process
Responsible for providing support to the QC Department of the Cell & Gene Therapies Business Unit for certain shared services including Raw Materials, QC Systems, Sample Logistics etc.
To approve or reject starting materials, packaging materials, intermediate, bulk and finished products
Responsible to ensure the QC operations comply to cGMP and safety regulations
Responsible to ensure QC participation in the multidisciplinary customer teams (IPT, JPT) and the global QC work teams
To lead the development and implementation of improvement systems in the area in line with the Operational Excellence strategy
Ensure escalation of non-compliance or ineffective Quality System deployment at site
Plan resources for QC to support projects and testing in alignment with production activities. To ensure that all necessary testing is carried out and the associated records evaluated
To lead the method transfer activities for customer projects in Quality Control
To lead from a QC standpoint audits/inspections by customers and/or regulatory agencies
To ensure the development and coaching of QC staff in order to improve their performance, abilities and competences
Drive the timely release of test results and approval of certificate of Analysis to support batch release
Ensure that product has been manufactured and tested in accordance with c GMP requirements, company SOPs, policies and specifications
To approve specifications, sampling instructions, test methods and other Quality Control procedures.
To ensure the qualification and maintenance of QC premises / equipment and appropriate validations are done
Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures
Any other duties as assigned by Site Quality Head
Key Requirements:
Bachelor's degree in Life Sciences is preferred; a combination of education and years of experience will be considered w ith 10+ years of QC experience
Proven experience in leadership positions
Leadership skills- ability to coach, manage and lead diverse teams
Demonstrated ability to present ideas publicly to inform, educate and influence others positively in achieving business results
Excellent communications skills both written and verbal format
Relate to others in a team setting. Active listener seeking to understand and to be understood. Able to coach and manage experienced and inexperienced staff
Maintain positive attitude and emotional composure in a team environment
Maintain control of meetings with direct reports
Mentoring and leading direct reports
Being able to deliver difficult messages to staff (i.e. disciplinary actions, poor performance plans)
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Quality Assurance Auditor
Posted today
Job Viewed
Job Description
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want you to be part of.
Job Summary:
The Head of Quality Control (QC) is responsible for Quality Control activities including biochemistry, microbiology, environmental monitoring, raw materials, stability, method transfer, instrument and software qualification, data integrity, sample management, and QC document management.
The Head of QC provides a safe, controlled work environment in all areas of responsibility while being aware of the site safety objectives and making sure these are communicated and understood by all staff. Provides guidance to supervisors and other frontline leads to achieve goals in accordance with established policies. Establishes and recommends changes to policies which affect subordinate organizations. Develops and administers budgets, schedules and performance requirements.
Role will be responsible for Championing operational excellence and innovation as well QC financial targets, to ensure stable planning of QC activities as per site needs. Responsible for people development and growth. Creates a culture in the QC organization that leads to employee satisfaction and retention. Contributes to the site’s growth strategy, including planning, budgeting, and safety .
Key Responsibilities:
Partners with the Site Quality Head, Site Leadership Team, and Global Quality functions in executing the strategic goals of the company
Lead the Quality Control Department for the Mammalian Business Unit at Lonza Portsmouth with responsibility for the following groups within the department: Raw Material, Analytical, Biochemistry, Microbiology, Environmental Monitoring, Assay validation/transfer, laboratory information and sample logistics and includes all personnel associated with the department i.e. FTE, interns and contractors
Develops and executes the QC strategy for the site. Ensures quality and delivery meets or exceeds internal stakeholder and customer expectations
Ov ersees raw materials testing, in-process and finished product testing, environmental monitoring and microbiology, stability testing, method transfer and validation, instrument and software qualification, QC data integrity, sample management, and QC document management
Drives continuous improvement initiatives to ensure that the QC organization meets key performance indicator goals
To evaluate and prioritize QC projects in the medium and long term, ensuring that the human, technical and financial resources are focused on the achievement of strategic objectives
Works closely with Program Management, Quality Assurance, Manufacturing Asset leadership, and customers to support project teams throughout the product lifecycle
Attends Site Quality Council (monthly) and other meetings as needed, e.g. Change Control Committee, Deviation Review Board, CAPA Board
Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance in resolving issues
Builds and maintains expertise in the QC organization, ensuring that the QC organization supports site operations through ongoing development of staff
Represents QC function in Joint Steering Committee meetings with customers
Supports Regulatory and Customer Audits as needed
Manages the QC budget process
Responsible for providing support to the QC Department of the Cell & Gene Therapies Business Unit for certain shared services including Raw Materials, QC Systems, Sample Logistics etc.
To approve or reject starting materials, packaging materials, intermediate, bulk and finished products
Responsible to ensure the QC operations comply to cGMP and safety regulations
Responsible to ensure QC participation in the multidisciplinary customer teams (IPT, JPT) and the global QC work teams
To lead the development and implementation of improvement systems in the area in line with the Operational Excellence strategy
Ensure escalation of non-compliance or ineffective Quality System deployment at site
Plan resources for QC to support projects and testing in alignment with production activities. To ensure that all necessary testing is carried out and the associated records evaluated
To lead the method transfer activities for customer projects in Quality Control
To lead from a QC standpoint audits/inspections by customers and/or regulatory agencies
To ensure the development and coaching of QC staff in order to improve their performance, abilities and competences
Drive the timely release of test results and approval of certificate of Analysis to support batch release
Ensure that product has been manufactured and tested in accordance with c GMP requirements, company SOPs, policies and specifications
To approve specifications, sampling instructions, test methods and other Quality Control procedures.
To ensure the qualification and maintenance of QC premises / equipment and appropriate validations are done
Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures
Any other duties as assigned by Site Quality Head
Key Requirements:
Bachelor's degree in Life Sciences is preferred; a combination of education and years of experience will be considered w ith 10+ years of QC experience
Proven experience in leadership positions
Leadership skills- ability to coach, manage and lead diverse teams
Demonstrated ability to present ideas publicly to inform, educate and influence others positively in achieving business results
Excellent communications skills both written and verbal format
Relate to others in a team setting. Active listener seeking to understand and to be understood. Able to coach and manage experienced and inexperienced staff
Maintain positive attitude and emotional composure in a team environment
Maintain control of meetings with direct reports
Mentoring and leading direct reports
Being able to deliver difficult messages to staff (i.e. disciplinary actions, poor performance plans)
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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Quality Assurance Auditor
Posted today
Job Viewed
Job Description
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Job Summary:
The primary responsibility of a QA Lot Review Specialist IV is the closeout of all documentation prior to the release of Production Batches. QA Lot Review Specialist IV is responsible for the coordination of documentation as well as all meetings to discuss release deliverables and guiding junior QA Specialist staff on review priorities for documentation. Documentation includes manufacturing batch records and ancillary documentation such as Lot Genealogy Reports, Quality Control Assays used in the production of Active Pharmaceutical Ingredients (API) at the Lonza Portsmouth Facility. Quality Assurance Lot Review Specialist IV makes decisions regarding simple and complex issues that arise during review of records and assists junior staff with decision making. Escalation to senior members of the QA Operations team is employed for minimal issues. QA Lot Review Specialist IV demonstrates understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, Regulatory expectations, as well as pro fessional skills of effective leadership, communication and listening. Regularly demonstrates leadership skills such as coaching, training and mentoring staff with regards to regulatory and Lonza expectations. Leads Process improvement team assignments. So me External Customer interaction may be required
This position requires full time presence at our Portsmouth, NH location.
Key Responsibilities:
Independent review and closure of manufacturing batch records.
Process knowledge is used to address complex issues with minimal management input and to assist junior levels with similar issues.
Ensures all events are investigated as required. The Specialist can identify all non- conformances (simple and complex), understands the GMP implications of the nonconformance, and knows what actions to take with minimal guidance from their management.
Participation in daily lot release meeting and other routine meetings as assigned by management.
Trains staff as required and guides junior QA specialists on review priorities.
Demonstrates skills that include understanding of quality systems, basic biologics manufacturing, Good Documentation practices, communication and listening.
Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
Supports daily management systems.
Perform other duties as assigned.
Key Requirements:
Bachelor’s Degree in Life Science. A combination of education and years of experience will be considered
5-10 years in a cGMP Environment
Knowledge of Microsoft Office Tools (Word, Excel, Outlook) is required; knowledge of cGMP preferred (ICH Q7a, CFR 210/211 CFR 820 etc.)
Attention to detail and critical thinking skills are required; knowledge of Trackwise, SAP are preferred
Excellent written and verbal communicator at all levels. Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint) preferred
Motivated self - starter who has high attention to detail and adoptable to changing priorities and reprioritization of workload
Works effectively individually and within a team environment with direction as required
Presents facts clearly and logically and understands other perspectives
Able to identify and act on situations that require escalation with / without guidance
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Quality Assurance Auditor
Posted today
Job Viewed
Job Description
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Job Summary:
The primary responsibility of a QA Lot Review Specialist IV is the closeout of all documentation prior to the release of Production Batches. QA Lot Review Specialist IV is responsible for the coordination of documentation as well as all meetings to discuss release deliverables and guiding junior QA Specialist staff on review priorities for documentation. Documentation includes manufacturing batch records and ancillary documentation such as Lot Genealogy Reports, Quality Control Assays used in the production of Active Pharmaceutical Ingredients (API) at the Lonza Portsmouth Facility. Quality Assurance Lot Review Specialist IV makes decisions regarding simple and complex issues that arise during review of records and assists junior staff with decision making. Escalation to senior members of the QA Operations team is employed for minimal issues. QA Lot Review Specialist IV demonstrates understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, Regulatory expectations, as well as pro fessional skills of effective leadership, communication and listening. Regularly demonstrates leadership skills such as coaching, training and mentoring staff with regards to regulatory and Lonza expectations. Leads Process improvement team assignments. So me External Customer interaction may be required
This position requires full time presence at our Portsmouth, NH location.
Key Responsibilities:
Independent review and closure of manufacturing batch records.
Process knowledge is used to address complex issues with minimal management input and to assist junior levels with similar issues.
Ensures all events are investigated as required. The Specialist can identify all non- conformances (simple and complex), understands the GMP implications of the nonconformance, and knows what actions to take with minimal guidance from their management.
Participation in daily lot release meeting and other routine meetings as assigned by management.
Trains staff as required and guides junior QA specialists on review priorities.
Demonstrates skills that include understanding of quality systems, basic biologics manufacturing, Good Documentation practices, communication and listening.
Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
Supports daily management systems.
Perform other duties as assigned.
Key Requirements:
Bachelor’s Degree in Life Science. A combination of education and years of experience will be considered
5-10 years in a cGMP Environment
Knowledge of Microsoft Office Tools (Word, Excel, Outlook) is required; knowledge of cGMP preferred (ICH Q7a, CFR 210/211 CFR 820 etc.)
Attention to detail and critical thinking skills are required; knowledge of Trackwise, SAP are preferred
Excellent written and verbal communicator at all levels. Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint) preferred
Motivated self - starter who has high attention to detail and adoptable to changing priorities and reprioritization of workload
Works effectively individually and within a team environment with direction as required
Presents facts clearly and logically and understands other perspectives
Able to identify and act on situations that require escalation with / without guidance
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Quality Assurance Auditor
Posted today
Job Viewed
Job Description
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Job Summary:
The primary responsibility of a QA Lot Review Specialist IV is the closeout of all documentation prior to the release of Production Batches. QA Lot Review Specialist IV is responsible for the coordination of documentation as well as all meetings to discuss release deliverables and guiding junior QA Specialist staff on review priorities for documentation. Documentation includes manufacturing batch records and ancillary documentation such as Lot Genealogy Reports, Quality Control Assays used in the production of Active Pharmaceutical Ingredients (API) at the Lonza Portsmouth Facility. Quality Assurance Lot Review Specialist IV makes decisions regarding simple and complex issues that arise during review of records and assists junior staff with decision making. Escalation to senior members of the QA Operations team is employed for minimal issues. QA Lot Review Specialist IV demonstrates understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, Regulatory expectations, as well as pro fessional skills of effective leadership, communication and listening. Regularly demonstrates leadership skills such as coaching, training and mentoring staff with regards to regulatory and Lonza expectations. Leads Process improvement team assignments. So me External Customer interaction may be required
This position requires full time presence at our Portsmouth, NH location.
Key Responsibilities:
Independent review and closure of manufacturing batch records.
Process knowledge is used to address complex issues with minimal management input and to assist junior levels with similar issues.
Ensures all events are investigated as required. The Specialist can identify all non- conformances (simple and complex), understands the GMP implications of the nonconformance, and knows what actions to take with minimal guidance from their management.
Participation in daily lot release meeting and other routine meetings as assigned by management.
Trains staff as required and guides junior QA specialists on review priorities.
Demonstrates skills that include understanding of quality systems, basic biologics manufacturing, Good Documentation practices, communication and listening.
Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
Supports daily management systems.
Perform other duties as assigned.
Key Requirements:
Bachelor’s Degree in Life Science. A combination of education and years of experience will be considered
5-10 years in a cGMP Environment
Knowledge of Microsoft Office Tools (Word, Excel, Outlook) is required; knowledge of cGMP preferred (ICH Q7a, CFR 210/211 CFR 820 etc.)
Attention to detail and critical thinking skills are required; knowledge of Trackwise, SAP are preferred
Excellent written and verbal communicator at all levels. Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint) preferred
Motivated self - starter who has high attention to detail and adoptable to changing priorities and reprioritization of workload
Works effectively individually and within a team environment with direction as required
Presents facts clearly and logically and understands other perspectives
Able to identify and act on situations that require escalation with / without guidance
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.