Quality Assurance Document Control

19117 Philadelphia, Pennsylvania Catalent Inc

Posted 1 day ago

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Job Description

Quality Assurance Document Control Associate

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This 206,878 square-foot facility, located in the Philadelphia area is Catalent’s global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.

Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Documentation Coordinator Associate (QADC). The position requires the individual to prepare customer files, review and approve batch records, and release batch records and finished product. The individual acts as the primary liaison to our customer’s quality assurance groups for batch record review and release. The position requires communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders.

This is a full-time role position: Monday-Friday 8:00am-4:30pm 1st Shift Hourly, Onsite.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role:

  • Independently manage assigned projects or support the Project Management (PM) team from award. Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.

  • Review of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures. Confirm proper randomization schedule utilization for correct patient treatment group assignment.

  • Primary liaison with client for batch release. Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation. Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements.

  • Ensure timely release of batch for protocol initiation date. Release batch within Scheduling database and within JDE inventory management system. Record and track errors and not-right-first-time to maintain departmental metrics.

  • Archive batch documents onto shared drive and within archive room. Coach new QADC staff through day to day activities when needed. Communicates SQDC counter measures and safety issues to Quality Management.

  • Ensures QADC metrics are met or takes action to correct. Complies with EH&S and 5S requirements for QADC.

  • All other duties as assigned;

The Candidate:

  • Requires a High School Diploma or GED; Bachelor's degree preferred

  • Must have basic computer skills, preferably with Microsoft Office and JDE

  • Prefer experience in Documentation including document review, data review, and Standard Operating Procedures etc

  • Previous Quality experience preferred

  • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

Why you should join Catalent:

  • Defined career path and annual performance review and feedback process

  • Diverse, inclusive culture

  • Positive working environment focusing on continually improving processes to remain innovative

  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

  • 152 hours of PTO + 8 paid holidays

  • Several Employee Resource Groups focusing on D&I

  • Dynamic, fast-paced work environment

  • Community engagement and green initiatives

  • Generous 401K match

  • Medical, dental and vision benefits

  • Tuition Reimbursement - Let us help you finish your degree or start a new degree!

  • WellHub- program to promote overall physical wellness

  • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers ( to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE ( .

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Quality Assurance Document Control

19117 Philadelphia, Pennsylvania Abacus

Posted 10 days ago

Job Viewed

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Job Description

Description/Comment: QADC
BASIC FUNCTION:
The position requires the individual to prepare customer files, review and approve batch records, and release batch records and finished product. The individual acts as the primary liaison to our customer's quality assurance groups for batch record review and release. The position requires communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders.
SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES:
• Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.
o Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.
• Monitor schedule for production priorities.
• Attend scheduling meetings when needed.
• Review of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures.
• Confirm proper randomization schedule utilization for correct patient treatment group assignment.
• Primary liaison with client for batch release.
• Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation. Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements.
• Ensure timely release of batch for protocol initiation date.
• Release batch within Scheduling database.
• Release batch within JDE inventory management system.
• Record and track errors and not-right-first-time to maintain departmental metrics.
• Archive batch documents onto shared drive and within archive room.
• Ensure that responsibilities are completed efficiently while maintaining Quality.
• Promotes a positive working environment.
• Coach new QADC staff through day to day activities when needed.
• Communicates SQDC counter measures and safety issues to Quality Management.
• Ensures QADC metrics are met or takes action to correct.
• Complies with EH&S and 5S requirements for QADC.
• Other tasks or projects as assigned.
POSITION REQUIREMENTS:
Supervises: N/A
Education or Equivalent: BA/BS or High School Diploma with relevant industry experience.
Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements)
o Attention to detail
o Good organizational/time management skills
o Exercises sound judgment and analytical in thought
o Challenges status quo and initiates improvements
o Ability to multi-task
o Communication skills
o Good math skills
o Basic computer skills Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 112 10381 Decatur Rd 05-0591182 Philadelphia PA 19114 United States Education: dditional Job Details: ONSITE - Contract for 12 months SHIFT - M-F 11 AM TO 730 PM TRAINING WILL BE AM HOURS FOR 3 MONTHS - 10 AM TO 630 PM. VET ACCORDINLY THIS IS NOT NEGOTIABLE This position will be doing Batch record review and approval, support all QA Document Control Functions including filing, review, approval, GMP review of batch records. Will be in a cubical environment and very fast paced and can be loud. Must have 1 year experience in GMP Laws (Good Manufacturing Practices). Prefer batch record review experience. Must be proficient in use of computers and Microsoft Office. Education: High school or 2-year degree

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Quality Assurance Document Control

19133 Philadelphia, Pennsylvania Catalent Pharma Solutions

Posted 6 days ago

Job Viewed

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Job Description

**Quality Assurance Document Control Associate**
**Position Summary:**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID safe storage labels for your studies. Single panel and Peel-ID safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.
Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Documentation Coordinator Associate (QADC). The position requires the individual to prepare customer files, review and approve batch records, and release batch records and finished product. The individual acts as the primary liaison to our customer's quality assurance groups for batch record review and release. The position requires communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders.
**This is a full-time role position: Monday-Friday** **8:00am-4:30pm 1st Shift** **Hourly, Onsite.**
**Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.**
**The Role:**
+ Independently manage assigned projects or support the Project Management (PM) team from award. Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.
+ Review of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures. Confirm proper randomization schedule utilization for correct patient treatment group assignment.
+ Primary liaison with client for batch release. Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation. Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements.
+ Ensure timely release of batch for protocol initiation date. Release batch within Scheduling database and within JDE inventory management system. Record and track errors and not-right-first-time to maintain departmental metrics.
+ Archive batch documents onto shared drive and within archive room. Coach new QADC staff through day to day activities when needed. Communicates SQDC counter measures and safety issues to Quality Management.
+ Ensures QADC metrics are met or takes action to correct. Complies with EH&S and 5S requirements for QADC.
+ All other duties as assigned;
**The Candidate:**
+ Requires a High School Diploma or GED; Bachelor's degree preferred
+ Must have basic computer skills, preferably with Microsoft Office and JDE
+ Prefer experience in Documentation including document review, data review, and Standard Operating Procedures etc
+ Previous Quality experience preferred
+ Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
**Why you should join Catalent:**
+ Defined career path and annual performance review and feedback process
+ Diverse, inclusive culture
+ Positive working environment focusing on continually improving processes to remain innovative
+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
+ 152 hours of PTO + 8 paid holidays
+ Several Employee Resource Groups focusing on D&I
+ Dynamic, fast-paced work environment
+ Community engagement and green initiatives
+ Generous 401K match
+ Medical, dental and vision benefits
+ Tuition Reimbursement - Let us help you finish your degree or start a new degree!
+ WellHub- program to promote overall physical wellness
+ Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .
View Now

Quality Assurance Document Control Associate

19133 Philadelphia, Pennsylvania Catalent Pharma Solutions

Posted 6 days ago

Job Viewed

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Job Description

**Quality Assurance Document Control Associate**
**Position Summary:**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID safe storage labels for your studies. Single panel and Peel-ID safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.
Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Documentation Coordinator Associate (QADC). The position requires the individual to prepare customer files, review and approve batch records, and release batch records and finished product. The individual acts as the primary liaison to our customer's quality assurance groups for batch record review and release. The position requires communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders.
**This is a full-time role position: Monday-Friday** **2:00pm - 10:30pm, 2nd Shift.** **Hourly, Onsite.**
**Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.**
**The Role:**
+ Independently manage assigned projects or support the Project Management (PM) team from award. Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.
+ Review of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures. Confirm proper randomization schedule utilization for correct patient treatment group assignment.
+ Primary liaison with client for batch release. Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation. Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements.
+ Ensure timely release of batch for protocol initiation date. Release batch within Scheduling database and within JDE inventory management system. Record and track errors and not-right-first-time to maintain departmental metrics.
+ Archive batch documents onto shared drive and within archive room. Coach new QADC staff through day to day activities when needed. Communicates SQDC counter measures and safety issues to Quality Management.
+ Ensures QADC metrics are met or takes action to correct. Complies with EH&S and 5S requirements for QADC.
+ All other duties as assigned;
**The Candidate:**
+ Requires a High School Diploma or GED; Bachelor's degree preferred
+ Must have basic computer skills, preferably with Microsoft Office and JDE
+ Prefer experience in Documentation including document review, data review, and Standard Operating Procedures etc
+ Previous Quality experience preferred
+ Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
**Why you should join Catalent:**
+ Defined career path and annual performance review and feedback process
+ Diverse, inclusive culture
+ Positive working environment focusing on continually improving processes to remain innovative
+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
+ 152 hours of PTO + 8 paid holidays
+ Several Employee Resource Groups focusing on D&I
+ Dynamic, fast-paced work environment
+ Community engagement and green initiatives
+ Generous 401K match
+ Medical, dental and vision benefits
+ Tuition Reimbursement - Let us help you finish your degree or start a new degree!
+ WellHub- program to promote overall physical wellness
+ Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .
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Quality Assurance Consultant

08534 Pennington, New Jersey Genesis10

Posted 6 days ago

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Job Description

Genesis10 is currently seeking a Quality Assurance Consultant with our client in the financial industry located in Pennington, NJ. This is a 12 + month contract position.

Responsibilities:

  • Accountable for ensuring that in-sprint testing, system integrated testing, end-to-end regression testing
  • Execute automation test scripts, reporting the testing status to management
  • Adhere to enterprise change management guidelines
  • Support the business partners during UAT and postproduction validation
  • Support the development team for critical defect triage
  • Responsible for all QA testing effort for CMC team and will report directly to test lead for Connected customer train
  • Determine general and specific quality requirements for products
  • Create manual and automated software tests to identify functionality issues
  • Analyze testing results and implement or communicate solutions to developers

Requirements:
  • 6+ years of experience as functional tester, defect management, change management process
  • 6+ years of testing Salesforce applications, Financial Services cloud or Marketing cloud
  • Experience with Mobile testing
  • Experience in SQL query
  • Experience in Agile Methodology
  • Experience in Tricentis Tosca automation
  • Experience using UFT or Selenium test automation
  • Ability to work closely and mentor other offshore team members
  • Organized, motivated, team-player, intellectually curious and able to thrive in a fast paced environment
  • Strong collaborative, organizational, problem-solving skills
  • Innovative and detail-oriented
  • Excellent written and verbal communication skills

Desired skills:
  • Salesforce admin certification or developer
  • Experience in Selenium



Pay range: $35.75 - $43.75

Only candidates available and ready to work directly as Genesis10 employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, please apply!

About Genesis10:

Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.

For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10:
* Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years.

* The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.

* Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)

* Behavioral Health Platform

* Medical, Dental, Vision

* Health Savings Account

* Voluntary Hospital Indemnity (Critical Illness & Accident)

* Voluntary Term Life Insurance

* 401K

* Sick Pay (for applicable states/municipalities)

* Commuter Benefits (Dallas, NYC, SF and Illinois)

For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.

Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Quality Assurance Specialst

19446 Lansdale, Pennsylvania Piper Companies

Posted 7 days ago

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Job Description

Piper Companies is currently looking for an experienced Quality Assurance Specialist in West Point, Pennsylvania (PA) to work for a innovative and growing pharmaceutical manufacturer.

Responsibilities for the Quality Assurance Specialist include:
• Review clinical/commercial electronic batch records and documentation for completeness and accuracy in preparation for batch release
• Correct and revise documentation as needed
• Advise manufacturing personnel on proper documentation
• Utilize knowledge of FDA and GMP regulations to ensure compliance
• Assist in Deviation/OOS investigations

Qualifications for the Quality Assurance Specialist include:
• A minimum of 1-5 years' experience within Pharmaceutical Manufacturing
• Hands on experince with Batch Record review
• Proficiency in Microsoft Office
• B.S. in business or scientific field preferred

Compensation for the Quality Assurance Specialist include:
• Salary Range is $65,000-$75,000 dependent upon experience.
• Comprehensive benefits package

Keywords

Quality Assurance Associate, QA, Pharmaceutical, FDA, GMP, Batch Record, Manufacturing, GDP, cGMP, Clinical Manufacturing, Regulatory Review, #LI-ONSITE #LI-DF1

This job opens for applications on 12/20/2024. Applications for this job will be accepted for at least 30 days from the posting date
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Quality Assurance Analyst

19488 Norristown, Pennsylvania Delphi-US

Posted 17 days ago

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Job Description

Job Title: QA Analyst III (Contract) - Job#5179

Location: Audubon PA

Responsibilities

The Quality Analyst will be responsible for test planning, test monitoring and control, test analysis and design, test implementation and test execution, evaluating exit criteria and reporting, and test closure. The Quality Analyst will be directly involved in hands-on, technical work including test data provisioning and test data management. Specific duties include the following.
  • Test planning: define the overall strategic and tactical objectives for testing software changes at different test levels. Work with developers, project managers and business customers to define the strategy to be used, such as risk-based testing. Test levels include component testing, integration testing, system testing and acceptance testing. Test types include functional testing, non-functional testing, structural ("white-box") testing, confirmation testing and regression testing.
  • Test monitoring and control: continuously compare test progress with the plan, adjust the plan and testing activities as necessary, and provide status reports.
  • Test analysis and design: transform testing objectives into test conditions and test cases. The test basis includes documented requirements, system architecture, behavior and structure of the software, existing data and data flows. Using structural ("white-box") test techniques, among others, design tests, or provide input into test design by identifying specific test conditions and high-level test cases.
  • Test implementation and test execution: develop and prioritize test procedures, set up the test environment and test data, and execute tests. Test changes to the database components of the system under test. Testable components include views, procedures and functions, data conversion and migration programs. Support business customers and others in acceptance testing. Includes identifying database model changes in higher environments (Production and Stage), and making those changes in the lower environments (Test and Development).
  • Evaluating exit criteria and reporting, and test closure: asses test execution against the objectives defined in the test plan. Specific tasks and deliverables are defined at the team or project level.
  • Identify the necessary test data to support test conditions and test cases as they are defined. Includes data to force error and boundary conditions. Analyze input data, including electronic files, message traffic and variations of user input.
  • Provide expected test results, and/or repeatable methods of generating expected test results, based on currently existing data. Includes preparing database queries and guides for testers to use.
  • Provide tools and methods to compare expected and actual test results. Includes bi-directional comparisons of database data with electronic files, message streams, and front-end displays.
  • Provide high-quality, realistic, fit for purpose and referentially intact test data. Capture end-to-end business processes and the associated data for testing. Subset production data: extract subsets of production data from multiple sources to meet test cases and/or to supply input values for data-driven testing. Create realistic test data sets small enough to support rapid test runs but large enough to accurately reflect the variety of production data.
  • Provide test data management. Script the setup of data in the application database to put it in a state that allows a specific set of test cases to be run against it. Script the creation of data files and message streams which require changing variables (usually date or timestamp related) in order to test applications which process them. Script database cleanups.
  • Be a specialist in the database layer of systems under test. Understand each database object's purpose and place in the technology stack, the business solutions it supports, and the business rules it encapsulates.
  • Assist software development and support teams in software product deployments. Includes deployment/build verification, and identification, analysis and troubleshooting of issues.
Required Skills
  • 7+ years of experience as a quality assurance analyst or tester
  • Strong customer and business focus
  • Strong communication skills
  • Understanding of Oracle RDBMS and SQL
  • Experience with test driven or behavior driven development practices
  • Someone who is energetic and passionate about their work, extremely positive and solution driven
  • Someone who has worked on large teams, on projects that have different business owners
  • Experience in defining test strategy/approach, test cases
  • Strong experience in the testing phase with business personnel, developers and management
  • Excellent knowledge of testing methodology (white vs. black box testing, function vs. path testing).
  • Experience developing testing artifacts, such as test plans and test cases
  • Experience working in multiple Software Development Life Cycle (SDLC) methodologies (Waterfall, Agile)
Preferred Skills
  • Experience in a SOA / Web Services environment
  • Experience using iterative development methodologies, specifically SCRUM
  • Experience using Xray for Jira or equivalent test management solutions
  • Experience using defect tracking tools - Jira preferred
  • Experience working hands on with databases - ability to write complex queries and joins
  • Experience using automated testing tools - SOAPUI, Cucumber, Selenium
  • Scripting experience using applicable languages (such as PL/SQL, Python, UNIX Shell, JavaScript, Perl, Ruby, HTML, DHTML, SOAP, XML, JCL, CICS)
  • Experience working with and testing logical data models
  • Experience as a software developer or architect
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Quality Assurance Analyst

19034 Fort Washington, Pennsylvania Katalyst Healthcares and Life Sciences

Posted 17 days ago

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Job Description

Responsibilities:
  • Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this position.
  • Ensure quality and compliance in all my actions
  • Attending GMP training on the schedule designated for my role and as appropriate for my role.
  • I adhere to strict compliance with procedures applicable to my role.
  • Exercise the highest level of integrity in the tasks that I perform.
  • In a timely and prompt manner, identify, report, and seek correction for deviations noted in my workplace.
  • Embrace a behavior of employee involvement and commitment to doing the job right the first time.
  • Ensure employees under your Product of responsibility are trained in required procedures for the execution of their role and maintain current training requirements during the year.
  • Promote an environment of employee involvement in the workplace.
  • Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.
  • Quality Assurance and Compliance Focus.
  • Provides daily 'Shop Floor" QA support to warehouse, bulk manufacturing, and packaging lines.
  • Provides leadership support to QA Shop Floor activities including communication of quality events to management.
  • Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.
  • Provides support to Investigations and/or Investigation Protocols, responsibilities include conducting, writing, reviewing and approvals.
  • Performs or supports activities related to Line Audits, Line or Area Cleaning Verifications.
  • Participates in design of quality processes and creation/modification/approval of Standard.
  • Operating Procedures (SOP's).
  • Provides support to Consumer Complaint investigations.
  • Provide QA support to various project teams, as needed.
  • Actively supports Site metrics, compliance improvement and training initiatives.
  • Customer and Performance Improvement Focus.
  • Provide support to capturing of site metrics and promote improvement opportunities.
  • Facilitate resolution of issues to improve site metrics.
  • People & Organization Focus.
  • Provides training and direction as needed for new employees.
  • Teams with Department members for process feedback and continuous improvement opportunities.
  • Represents Quality Assurance in a positive manner.
  • Performs other related duties as required.
Requirements:
  • 3-5 years Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement.
  • Technical B.S. or B.A. College Degree in Science is preferred.
  • Active cGMP Interpretation and Application Experience.
  • Demonstrated leadership- possesses the ability to lead a team.
  • Strong Organizational Skills.
  • Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation).
  • Problem Solving/Investigation Experience.
  • Expertise in Handling Multiple Priorities.
  • Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance.
  • Investigation Documentation.
  • Experience with Liquid Dose processing and packaging technology preferred.
  • Validation Experience preferred.
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Quality Assurance Director

19117 Philadelphia, Pennsylvania Day & Zimmermann

Posted 23 days ago

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Job Description

About Day and Zimmermann

No problem is too challenging or complex for Day & Zimmermann Maintenance and Construction (DZMC) because We do what we say! We're here to make life easier for plant owners in the Power, Chemical, and Industrial markets. With our wide-ranging capabilities and long-standing industry experience, we deliver innovative solutions and seamless processes that effectively manage all aspects of the plant life cycle. It's no wonder we're the #1 maintenance services provider in the United States. Come join in on our purpose - We put people to work, we protect American freedoms, and we help our customer's power and improve the world!

Position Description

We're looking for a full-time, staffDirector, Quality Assurance to join ourDay & Zimmermann team.

Provide Quality Assurance management direction and oversight for QA programs including Nuclear, DOE, DoD, Solar and ISO programs.Manage all QA procedures and verify proper imlementation and address all related issues. Assures through oversight that Quality Assurance activities for the company and venders are defined, planned, implemented and documented in accordance with client, company and industry standards.

As the Director Quality Assurance, here's the work you'll do:
  • Provide direction and oversight of QA Programs - DOE, DoD, Nuclear, Solar, ISO-9001
  • Assures through oversight that Quality Assurance activities for the company and suppliers are defined, planned, implemented and documented in accordance with client, company and industry standards
  • Establish and coordinates all audit activities for all business units and project organizations. This includes all vendor and supplier audits and maintain the corporate's Approved Supplier Lists.
  • Coordinates activities to ensure that Quality Program budgets, schedules and priorities are met.
  • Advises senior quality management and business unit managers of quality related deficiencies, audit findings, regulatory and third party inspection issues. Provides recommended resolution of the identified quality issues

This role is for you if you have these skills:
  • Analytical ability to grasp key factors from detailed specifications
  • Effective verbal communication and report writing skills
  • Working knowledge of construction industry Codes and Standards - Welding Processes
  • Good leadership capabilities to lead quality initiatives to successful completion
  • Basic knowledge of applicable software to compile quality process data. Familiar with the tools, concepts and methodologies of quality management

And if you have these qualifications:

* College degree or equivalent experience

* 15 years Quality related experience

* Lead Auditor, Auditor Certification

In compliance with this state's pay transparency laws, the salary range for this role is $124,080 - $186,120. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. (The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements).

We care about our employees, and it shows. Our staff receive a competitive salary and a comprehensive benefits package which includes medical/Rx, dental and vision coverage; life, AD&D and disability insurance; flexible spending accounts; 100% paid maternity leave for up to 12 weeks, parental leave, family leave, other paid time off; voluntary benefits and discount programs to meet our employees' individual needs including pet insurance for our furry family members!

To ensure a safe work environment while meeting the physical demands of the job, you must be able to perform the following physical and mental tasks, with or without a reasonable accommodation:

* Visual acuity (e.g., needed to prepare and analyze data, to transcribe documents, to view a computer, to read, to inspect objects, to operate machinery * Balancing (e.g., maintaining equilibrium when walking, climbing, crouching etc.) * Stooping (e.g., bending the spine at the waist) * Walking * Kneeling, crouching or crawling * Manual Dexterity (e.g. picking, pinching, typing, or other working that uses fingers) * Grasping (e.g., use of hand of apply pressure) * Feeling (e.g. perceiving an object's size, shape, texture etc.) * Climbing (e.g. ascending/descending ladders, stair, scaffolding, ramps, pole etc. using feet and legs or hands/arms to climb) * Hearing * Talking * Capacity to think, concentrate and focus over long periods of time * Ability to read/write complex documents in the English language * Capacity to reason and make sound decisions * Capacity to express thoughts orally * Ability to regularly perform all job functions at company's office or work site * Travel required 30%

SO WHAT ARE YOU WAITING FOR? APPLY NOW! Talent Acquisition Partner: Ashley Mitchell

Diversity, Inclusion & Equal Employment Opportunity

Day & Zimmermann is committed to maintaining an inclusive workforce, where employees are hired, retained, compensated and promoted based on their contributions to our Company. Our collective strength is rooted in over a century of diverse employees and businesses, commitment to success, and delivery on promises made. Federal and state Equal Employment Opportunity laws prohibit employment discrimination based on race, color, religion, sex, sexual orientation, age, national origin, citizenship status, veteran status and disability status. Day & Zimmermann is committed to providing an equal opportunity work environment in full compliance with these laws. If you are an individual with a disability and you require an accommodation in the application process, please , and please specify which position you are interested in, including job title and location.

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Quality Assurance Consultant

08534 Pennington, New Jersey DaVita

Posted today

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Job Description

Genesis10 is currently seeking a Quality Assurance Consultant with our client in the financial industry located in Pennington, NJ, Charlotte, NC, and Plano, TX. This is a 12+ month contract position. Responsibilities: Accountable to ensure in-sprint testing, system integrated testing, end to end regression testing Execute automation test scripts, report the testing status to management, adhere to enterprise change management guidelines Support the business partners during UAT and postproduction validation Support the development team for critical defect triage Responsible for all QA testing effort for GRE Integration team and will report directly to test lead for Connected customer train Determine general and specific quality requirements for products Create manual and automated software tests to identify functionality issues Analyze testing results and implement or communicate solutions to developers Support postproduction validation during weekends Requirements: 6+ years of experience as functional tester, defect management, change management process 6+ years of testing Salesforce applications, Financial Services cloud or Marketing cloud Experience with Mobile testing Experience in SQL query Experience with Agile Methodology Experience with Tricentis Tosca automation Experience with UFT or Selenium test automation Ability to work closely and mentor other offshore team members Organized, motivated, team-player, intellectually curious and able to thrive in a fast paced environment Strong collaborative, organizational, problem-solving skills Innovative and detail-oriented Excellent written and verbal communication skills Functional/Manual Testing Automation Testing Desired skills: Salesforce admin certification or developer Experience in Selenium Pay Range: $49.37-$57.37 Only candidates available and ready to work directly as Genesis10 employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, please apply! About Genesis10: Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals. For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10: * Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years. * The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years. * Access to an experienced, caring recruiting team (more than 7 years of experience, on average.) * Behavioral Health Platform * Medical, Dental, Vision * Health Savings Account * Voluntary Hospital Indemnity (Critical Illness & Accident) * Voluntary Term Life Insurance * 401K * Sick Pay (for applicable states/municipalities) * Commuter Benefits (Dallas, NYC, SF and Illinois) For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website. Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. #J-18808-Ljbffr

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