Johnson & Johnson Careers
Manager, Quality Control
Requisition ID: 5748180703
Janssen Supply Group, LLC. A member of the J&J Family of Companies, is recruiting for a Manager, Quality Control to be located in Athens, Georgia.
Janssen Supply Group, LLC is a global organization responsible for producing and supplying medicines to markets around the world. With quality as its primary focus, this group collaborates with Research & Development and Commercial partners to deliver life-changing solutions for patients in need.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it
The Quality Control Manager plans, coordinates, and directs the Quality Control Department and QC programs to ensure timely testing/release of materials and products in compliance with all local, state and federal regulations and guidelines (including FDA, DEA, EPA, and OSHA) as well as all company and site policies and procedures.
In this role, you will develop and deploy functional strategy within the department, provide the framework for effective teamwork, set objectives, and ensure the development of all laboratory personnel. This position also provides QC guidance and support throughout the Janssen Supply Chain (JSC) for new initiatives, projects, product transfers and regulatory inspections.
Main responsibilities include but are not limited to:
- Act as the primary contact for site leadership for analytical testing-related inquiries
- Maintain a customer-centric mentality in consistently meeting the needs of Quality Control’s key stakeholders (Quality Assurance, Manufacturing, Planning, and Technical Operations)
- Maintain a safe work environment in compliance with all applicable environmental, health, and safety regulations
- Contribute to local and global strategies related to QC laboratories which align with compliance and business objects as well as the overall Janssen and J&J vision
- Improve the efficiency of QC Operations through the use of Process Excellence and Lean principles
- Review and/or approve quality documents (standard operating procedures, specifications, test methods, work instructions, risk assessments, technical/validation protocols and reports, etc.), non-conformance investigations, CAPA, and change controls associated with the QC laboratories
- Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards. Make QC disposition decisions regarding the compliance of batches within established release specifications and trend limits
- Support internal and external audits, including external contract laboratories and GMP service providers, where required
- Lead as a laboratory subject matter expert during Health Authority inspections
- Immediately escalate potential product quality issues
- Support the investigation and resolution of customer complaints
- Analyze laboratory performance and quality data for quarterly site management and annual product reviews
- Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia
- Lead Quality risk assessment teams
- Ensure the QC laboratories are maintained in an organized and orderly state
- A minimum of a Bachelor’s degree is required. Advanced degree preferred.
- A minimum of 8 years of related experience is required.
- Experience directly managing/supervising employees is required
- Experience leading cross-functional, multi-site, and/or global teams is required.
- Expert knowledge of analytical technologies used in the QC laboratory (for example: HPLC/UHPLC, GC, Karl Fisher, FT-IR, NIR, Raman, Optical Rotation, UV/Vis, etc.) is required.
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems required.
- Understanding of ICH Q7 and/or 21 CFR parts 210 and 211 is required
- Detailed knowledge of compendial (USP, EP, JP, etc.) requirements and standards for QC testing is required.
- Experience working in a DEA-regulated environment and handling of controlled substances is preferred.
- Expertise in troubleshooting complex laboratory issues with strong reasoning skills in support of ongoing laboratory investigations is required.
- Strong interpersonal and written/oral communication skills is needed.
- Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required.
- Ability to manage multiple priorities daily while being flexible and responsive to frequently shifting priorities.
- Ability to independently manage a portfolio of ongoing projects is required.
- Detailed knowledge of financial concepts and terminology associated with capital project/budget responsibilities of the position is preferred.
- Knowledge and experience in applying statistical concepts to laboratory data is required.
- Knowledge of requirements for managing a stability program is required.
- Certification and/or experience applying Process Excellence (Six Sigma and/or Lean) tools and methodologies is desirable.
- This position is located in Athens, Georgia and may require up to domestic and international travel as business demands.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Janssen Pharmaceuticals, Inc (6062)