15 Bristol Myers Squibb jobs in Monmouth Junction

**Senior Quality Control / Quality Systems Consultant**
Looking for a quality professional with over 10 years of experience in the pharmaceutical and biotechnology industry, specializing in **Quality Control (QC), Quality Systems, Analytical Method Validation** , and **Global Specification Management** . Demonstrates proven expertise in leading laboratory operations, managing cross-functional teams, and driving global standardization and digital transformation initiatives within highly regulated environments.
**Education Requirement:**
bachelor's degree or higher in **Chemistry** or a related scientific discipline is required.
**Key Responsibilities:**
+ Oversee and coordinate **daily equipment qualifications** in QC laboratories, collaborating with cross-functional teams to ensure timely execution.
+ Lead **analytical method validations** , managing project timelines, resource allocation, and testing execution.
+ Author and review technical documentation, including **SOPs, test methods, validation master plans** , and analytical reports in compliance with regulatory requirements.
+ Support **IQ/OQ/PQ execution, calibration activities** , and overall lab readiness in coordination with internal departments.
+ Provide oversight for **change control processes** , including authoring and reviewing documentation in systems such as **TrackWise** and **Veeva Vault Quality Docs** .
+ Lead the **digital transformation of QC systems** as Product Owner for **Empower CDS** , managing a global cross-functional team using **Agile project management** practices.
+ Manage operations in a high-throughput **stability testing lab** , leading a team of analysts and implementing **Lean Lab** and **5S** principles to increase productivity and reduce costs.
+ Conduct **investigations (OOS, deviations)** , perform **risk assessments** and **root cause analyses** , and implement **CAPAs** in alignment with **cGMP** and **data integrity** standards.
+ Oversee **data review and documentation compliance** , developing and maintaining SOPs to meet evolving regulatory requirements.
+ Coordinate **stability programs** end-to-end, including protocol updates, change control evaluations, and cross-functional collaboration with Regulatory, QA, and Supply Chain.
+ Perform hands-on **analytical testing** for finished products, stability studies, and technical transfer, while reviewing data for regulatory filings and batch release.
+ Provide technical leadership for **LIMS** and **electronic data archiving systems** , ensuring compliance with **FDA** and **ICH** guidelines during audits and inspections.
+ Contribute to the creation and maintenance of **product specifications** for raw materials, APIs, packaging components, and finished products in accordance with **USP, ICH** , and **CFR** standards.
**Tools & Systems:**
+ **Empower CDS (Waters), TotalChrom**
+ **TrackWise** , **LIMS** , **Veeva Vault Quality Docs, ComplianceWire**
**Key Areas of Expertise:**
+ Analytical Method Validation & Transfer
+ Equipment Qualification (IQ/OQ/PQ); Change Control & CAPA Management
+ Stability Program Oversight
+ Data Integrity & ALCOA+ Principles
+ GMP/GLP Compliance; Regulatory Submissions & Audit Readiness
+ Laboratory Operations & Team Leadership
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

**Job Summary**
The QC Sampler is responsible for sampling all incoming materials such as raw materials, packaging components, printed material and all other GMP materials using established Standard Operating Procedures (SOPs) and working in accordance with current Good Manufacturing Practices (cGMP). Collect, sample, and prepare QC Chemical test samples for various analysis laboratories when required.
**Area Of Responsibility**
+ Sample all incoming materials and packaging materials per procedures.
+ Inspect all incoming GMP materials per materials specifications Inspect all incoming GMP materials per materials specifications including Identify non-conforming materials cleanliness and defects.
+ Follow work-flow procedures from receiving test samples, monitoring inventories, to waste disposal
+ Train towards Visual Inspection qualifications
+ Accurately sample and weigh Chemical test samples according to Material Specifications and SOPs using, at times, sterile operating procedures
+ Perform QC Release testing for Visual Inspection of cosmetic defects and dimensional inspection of product container closure components
+ Initiate product non-conforming reports (UPD) as required (Track Wise) and investigate any problems noted with sampling/inspection process.
+ Issue/Dispense and receive labels and packaging materials per production batch record. Keep inventory of all product label/packaging materials
+ Enter transactions/transfers into SAP inventory control system
+ Maintain records/manual log books per good documentation practices (GDPs)
+ Coordinate scrap removal of rejected product
+ Update Raw Material Specifications (RMS)/(SOPs) as needed
+ Work under general supervision and follows established procedures and instructions
+ Operate and maintain the QC Chemical Sampling laboratory to GMP compliance and safety compliance
+ Operate, maintain and clean, and calibrate balances
+ Maintain laboratory supplies, reagents, chemicals, and equipment inventories for Sampling and Inspection laboratories
+ Manage calibration of instruments and equipment used for inspection and perform monthly equipment/ instrument maintenance and cleaning.
+ Other duties as assigned
**Work Conditions:**
Warehouse Environment
Laboratory environment:
+ Exposure to noise, bio-hazardous (live cultures), and chemicals
+ Exposure to non-hazardous and hazardous chemicals and materials
+ Moderate noise, oven heat, open flame, chemical fume hoods areas requiring wearing appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)
**Physical Requirements:**
+ Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands, talk or hear, stoop, kneel, crouch or crawl.
+ Able to operate basic mechanical tools (i.e.:) calipers, micrometers, and go no-go gages
+ Able to drive a fork truck/tow motor/operate forklift
+ Close vision; depth perception; ability to adjust focus
+ Use of repetitive motion
+ Able to operate computer/office machines
+ Able to lift and carry up to 50 lbs.
**Travel Estimate**
Up to 5 %
**Education and Job Qualification**
+ Minimum of High School/Trade School/Vocational School Diploma, GED, or equivalent. B.S. degree preferred.
+ The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
+ Good oral and written communication skills and ability to use these skills to follow specific instruction and report assay results (i.e. written SOPs)
+ Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.)
+ Fundamental knowledge of chemical principles
+ Proficient with basic laboratory instrumentation.
+ Use of Track Wise software and knowledge of SAP is preferred.
+ Use of Lotus Notes software
+ Working knowledge of Microsoft Office Applications.
+ A self-starter with a hands-on approach and a can-do attitude.
**Experience**
+ Minimum of two (2) years of experience required in a Pharmaceutical/drug (FDA Regulated) industry preferred
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Chattem Chemicals, Inc. (a Sun Pharma Company) has a rich history as part of Chattem, Inc, which was founded as the Chattanooga Medicine Company on February 21, 1879. Today Chattem Chemicals, Inc. manufacturers a broad variety of products in four primary markets: Active Pharmaceutical Ingredients, Catalysts, Surfactants & Performance Additives.
Responsibilities:
1. Analytical support to all departments.
1. Support to regular QC activities, as required.
1. Method development, including validation and documentation.
1. Writing concise and timely reports to management on projects and regular activities.
1. Responsible for customer complaint investigations.
1. Assisting with technician training.
1. Other duties, as assigned.
Qualifications:
1. Bachelor of Chemistry degree (or related degree)
2. Knowledge of basic chemistry principles and analytical methods.
3. Working knowledge of cGMP as they relate to lab activities.
4. Careful attention to detail.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Job Title: QC Analyst II
Location: Piscataway, NJ
Hours/Schedule: M-F, 8:30 am - 5:00 pm (May require extended hours or weekends during manufacturing runs)
Type: Direct Hire / Permanent
Overview
We are seeking a QC Analyst II with a strong background in small molecule and protein chemistry to support our client's QC laboratory in a cGMP-compliant environment. The role involves analytical testing and data verification to support both late-stage clinical and commercial products, including biosimilars. The ideal candidate will be skilled in troubleshooting analytical results and working with cross-functional teams on projects, process improvements, and laboratory investigations.
Responsibilities
+ Perform analytical testing and data verification to support in-process, release, raw materials, and stability programs.
+ Conduct testing using HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, and ELISA.
+ Collaborate across departments to resolve project issues, conduct lab investigations, and implement process improvements.
+ Document and investigate Out of Specification results, deviations, and implement corrective actions.
+ Support regulatory inspections and prepare dossiers for agency interactions.
+ Maintain laboratory equipment and comply with all company policies, standards, and regulatory guidance.
Requirements
+ Bachelor's degree in Biotechnology, Biochemistry, Chemistry or related field with a minimum of 8 years of QC experience in pharma / biotech.
+ OR Master's Degree in the above fields with 6 years of QC experience in pharma / biotech
+ Prior experience in a cGMP laboratory is essential
+ Strong knowledge in protein and small molecule chemistry and proficiency with techniques such as HPLC, SDS-PAGE, ELISA, and capillary electrophoresis
+ Experience with SOPs, QC methods, and regulatory dossiers
+ Demonstrated ability to support regulatory inspections (e.g. PAI)
Working Environment
+ Primarily lab-based with some office work for documentation
+ Must be able to lift 25 lbs
+ Travel up to 5%-10% as needed (between Piscataway and South Plainfield locations)
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
#M3
Ref: #558-Scientific
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The **Quality Control Inspector Supervisor** will be overseeing the quality control inspection activities to ensure the safety, efficacy, and quality of the company's medical devices. This role is expected to provide technical and supervisory leadership and mentoring to the quality control inspectors and provides support to management. This job is expected to work onsite. Must have working knowledge of U.S. Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies.
**ESSENTIAL DUTIES AND RESPONSIBILITIES**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
+ Oversee all activities related to quality control inspection, including product inspection, incoming material inspection, and management of quarantined materials.
+ Perform scheduling and delegation of duties for the quality control inspection team.
+ Coordinates production activities with Operations teams and schedules QC personnel to support these activities across weekend shifts.
+ Communicate with operations to ensure the priorities needed for production are covered.
+ Responsible for reviewing and approving QC results, including incoming and in-process inspections.
+ Reports any non-conformances in a timely manner.
+ Author and/or support non-conformance and CAPA investigations as required.
+ Author or revise Standard Operating Procedures (SOPs).
+ Participates in FDA inspections, ISO certifications, surveillance audits, and customer audits.
+ Interpret and work within the guidelines of drawings, specifications, charts, procedures, and other data to determine product or material acceptance.
+ Maintain GMP documentation and adhere to Good Documentation Practices.
+ Read and interpret sampling plan as per the American National Standard Institute (ANSI).
+ Oversees physical and electronic quarantine locations.
+ Provides staff with leadership, support, and mentoring. Conducts performance reviews for lab personnel, holds regular team meetings, and provides training to junior staff as needed.
+ May also perform other related duties, responsibilities, and special projects as assigned.
**DESIRED MINIMUM QUALIFICATIONS**
+ Bachelor's degree or higher in Science, Engineering, or related fields is desired.
+ 7+ years of relevant GMP/GLP laboratory experience in regulated industry, with supervisory and/or project leadership experience.
+ Must have strong written and verbal communication skills. Must be able to effectively present at staff and department meetings.
+ Knowledge of MS Office Suite
+ Knowledge of Oracle R12 and/or Agile PLM preferred.
**PHYSICAL REQUIREMENTS**
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must speak and write in English. The employee is required to go to all areas of the company, including the manufacturing cleanrooms. The employee may be required to periodically lift and/or move up to 25lbs. The employee requires visual acuity and color perception adequate to perform job duties. Eyesight correctable to 20/25 to detect the presence of defined defect classifications in/on product/materials.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law ( | EOE including Disability/Protected Veterans ( LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA ( . If you have difficulty using our online system due to a disability and need an accommodation, please email us at
Integra - Employer Branding from Integra LifeSciences on Vimeo (

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

A Quality Control (QC) Inspector II plays a critical role in ensuring that products meet the required safety, performance, and regulatory standards before they reach the market. Their responsibilities typically include:

Inspection and Testing: QC Inspectors examine raw materials, in-process components, and finished products for defects, inconsistencies, or non-compliance with established specifications. They perform visual, mechanical, and sometimes functional tests to ensure products meet regulatory requirements (such as FDA or ISO standards).

Documentation and Reporting: They maintain detailed records of inspections, test results, and any deviations from quality standards. They document any non-conformities, assist with root cause analysis, and work with engineering or production teams to address issues.

Regulatory Compliance: Ensure that all processes and products comply with industry regulations, such as FDA's Good Manufacturing Practices (GMP) or ISO 9001, ISO 13485 standards. They may be involved in preparing for audits and assisting with the implementation of corrective and preventive actions (CAPA).

Collaboration with Teams: They work closely with production, engineering, and design teams to resolve quality issues and contribute to continuous improvement initiatives, such as process optimizations or design changes to enhance product quality.

Training and Support: They may provide training to production staff on quality standards and best practices, and occasionally, they might also assist in the development of standard operating procedures (SOPs) for inspection processes.

QC Inspectors in medical device companies play a crucial role in maintaining product integrity and ensuring that devices are safe and effective for patient use.

This role will be on the Weekend Shifts Friday, Saturday and Sunday - 1st Shift (12 hours per shift)

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Perform inspection by using a variety of inspection measuring and test equipment to determine acceptance or rejection of material or parts.
• Perform first article, incoming/receiving, and in-process inspections of materials or parts; determine acceptance or rejection after inspection and/or testing of materials, parts, and/or equipment.
• Interpret and work within the guideline of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
• Read and interpret sampling pan as per the American national standard institute (ANSI),
• Assist in the review and disposition of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
• Maintain accurate and current inspection and/or testing records such as nit not limited to Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification.
• Coordinate and inform other departments of inspection and/or testing status in support of production and project goals and initiatives.
• Promote and participate in continuous improvement initiatives.
• Responsible for the maintenance of appropriate conditions of all quarantine locations.
• Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
• Inspection requirements include training and working in classified clean rooms as necessary to perform in process inspections.
• Maintain records of inspection and all testing performed on the appropriate test records.
• Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
• Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
• Provide quality support to various departments as needed, e.g. engineering, product development, etc.)
• Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
• May also perform other related duties, responsibilities, and special projects as assigned.

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Associate degree in science is preferred.
• 3-7 years of relevant GMP/GLP experience specific to incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry.
• QA experience in the medical device industry preferred.
• Must have strong written and verbal communication skills.
• Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
• Knowledge of CAPA, Validations, Change Control, preferred.
• Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP.
• Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
• Ability to define problems, collect data, establish facts and draw valid conclusions
• Ability to work effectively in a cross functional environment
• Ability to integrate quality objectives across multiple functions
• Attention to detail, strong time management are essential
• Must be able to work independently with minimal supervision.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at or call us at .

Integra - Employer Branding from Integra LifeSciences on Vimeo

Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
A **Quality Control (QC) Inspector II** plays a critical role in ensuring that products meet the required safety, performance, and regulatory standards before they reach the market. Their responsibilities typically include:
Inspection and Testing: QC Inspectors examine raw materials, in-process components, and finished products for defects, inconsistencies, or non-compliance with established specifications. They perform visual, mechanical, and sometimes functional tests to ensure products meet regulatory requirements (such as FDA or ISO standards).
Documentation and Reporting: They maintain detailed records of inspections, test results, and any deviations from quality standards. They document any non-conformities, assist with root cause analysis, and work with engineering or production teams to address issues.
Regulatory Compliance: Ensure that all processes and products comply with industry regulations, such as FDA's Good Manufacturing Practices (GMP) or ISO 9001, ISO 13485 standards. They may be involved in preparing for audits and assisting with the implementation of corrective and preventive actions (CAPA).
Collaboration with Teams: They work closely with production, engineering, and design teams to resolve quality issues and contribute to continuous improvement initiatives, such as process optimizations or design changes to enhance product quality.
Training and Support: They may provide training to production staff on quality standards and best practices, and occasionally, they might also assist in the development of standard operating procedures (SOPs) for inspection processes.
QC Inspectors in medical device companies play a crucial role in maintaining product integrity and ensuring that devices are safe and effective for patient use.
**This role will be on the Weekend Shifts Friday, Saturday and Sunday - 1st Shift (12 hours per shift)**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
+ Perform inspection by using a variety of inspection measuring and test equipment to determine acceptance or rejection of material or parts.
+ Perform first article, incoming/receiving, and in-process inspections of materials or parts; determine acceptance or rejection after inspection and/or testing of materials, parts, and/or equipment.
+ Interpret and work within the guideline of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
+ Read and interpret sampling pan as per the American national standard institute (ANSI),
+ Assist in the review and disposition of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
+ Maintain accurate and current inspection and/or testing records such as nit not limited to Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification.
+ Coordinate and inform other departments of inspection and/or testing status in support of production and project goals and initiatives.
+ Promote and participate in continuous improvement initiatives.
+ Responsible for the maintenance of appropriate conditions of all quarantine locations.
+ Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
+ Inspection requirements include training and working in classified clean rooms as necessary to perform in process inspections.
+ Maintain records of inspection and all testing performed on the appropriate test records.
+ Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
+ Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
+ Provide quality support to various departments as needed, e.g. engineering, product development, etc.)
+ Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
+ May also perform other related duties, responsibilities, and special projects as assigned.
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
+ Associate degree in science is preferred.
+ 3-7 years of relevant GMP/GLP experience specific to incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry.
+ QA experience in the medical device industry preferred.
+ Must have strong written and verbal communication skills.
+ Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
+ Knowledge of CAPA, Validations, Change Control, preferred.
+ Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP.
+ Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
+ Ability to define problems, collect data, establish facts and draw valid conclusions
+ Ability to work effectively in a cross functional environment
+ Ability to integrate quality objectives across multiple functions
+ Attention to detail, strong time management are essential
+ Must be able to work independently with minimal supervision.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law ( | EOE including Disability/Protected Veterans ( LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA ( . If you have difficulty using our online system due to a disability and need an accommodation, please email us at or call us at .
Integra - Employer Branding from Integra LifeSciences on Vimeo (

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Quality Inspector I will be responsible for performing quality assurance inspections on purchased components, manufactured sub-assemblies and final product. The Quality Inspector will perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and able to measure critical dimensions.

Shift Details: 2nd Shift (10 hours) Monday to Thursday

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Perform inspection by using a variety of inspection measuring and test equipment to determine acceptance or rejection of material or parts.
• Perform first article, incoming/receiving, and in-process inspections of materials or parts; determine acceptance or rejection after inspection and/or testing of materials, parts, and/or equipment.
• Interpret and work within the guideline of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
• Read and interpret sampling pan as per the American national standard institute (ANSI)
• Assist in the review and disposition of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
• Maintain accurate and current inspection and/or testing records such as nit not limited to Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification.
• Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
• Inspection requirements include training and working in classified clean rooms as necessary to perform in process inspections.
• Maintain records of inspection and all testing performed on the appropriate test records.
• Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
• Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
• May also perform other related duties, responsibilities, and special projects as assigned.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• High School Diploma.
• 1-2 years of relevant GMP/GLP experience specific to incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry.
• QA experience in the medical device industry preferred. •Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
• Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP preferred.
• Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to work effectively in a cross functional environment.
• Ability to integrate quality objectives across multiple functions.
• Attention to detail and strong time management are essential.
• Must be able to work independently with minimal supervision.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at or call us at .

Integra - Employer Branding from Integra LifeSciences on Vimeo

Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The **Quality Inspector I** will be responsible for performing quality assurance inspections on purchased components, manufactured sub-assemblies and final product. The Quality Inspector will perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and able to measure critical dimensions.
**This is a 2nd shift role, 10-hour shifts Monday to Thursday**
ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
+ Perform inspection by using a variety of inspection measuring and test equipment to determine acceptance or rejection of material or parts.
+ Perform first article, incoming/receiving, and in-process inspections of materials or parts; determine acceptance or rejection after inspection and/or testing of materials, parts, and/or equipment.
+ Interpret and work within the guideline of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
+ Read and interpret sampling pan as per the American national standard institute (ANSI)
+ Assist in the review and disposition of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
+ Maintain accurate and current inspection and/or testing records such as nit not limited to Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification.
+ Coordinate and inform other departments of inspection and/or testing status in support of production and project goals and initiatives.
+ Promote and participate in continuous improvement initiatives.
+ Responsible for the maintenance of appropriate conditions of all quarantine locations.
+ Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
+ Inspection requirements include training and working in classified clean rooms as necessary to perform in process inspections.
+ Maintain records of inspection and all testing performed on the appropriate test records.
+ Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
+ Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
+ Provide quality support to various departments as needed, e.g. engineering, product development, etc.)
+ Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
+ May also perform other related duties, responsibilities, and special projects as assigned.
**DESIRED MINIMUM QUALIFICATIONS** The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
+ Minimum HS Diploma
+ 0+ years of relevant GMP/GLP experience specific to incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry.
+ QA experience in the medical device industry preferred.
+ Must have strong written and verbal communication skills.
+ Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
+ Knowledge of CAPA, Validations, Change Control, preferred.
+ Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP.
+ Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
+ Ability to define problems, collect data, establish facts and draw valid conclusions
+ Ability to work effectively in a cross functional environment
+ Ability to integrate quality objectives across multiple functions
+ Attention to detail, strong time management are essential
+ Must be able to work independently with minimal supervision.
**PHYSICAL REQUIREMENTS**
+ The employee may be required to periodically lift and/or move up to 25lbs.
+ Role requires employees to pass a visual acuity test. Vision aids, such as glasses or contact lenses, are allowed and must be worn during visual inspections if needed to pass the test.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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EEO Is the Law ( | EOE including Disability/Protected Veterans ( LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA ( . If you have difficulty using our online system due to a disability and need an accommodation, please email us at
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