Quality Assurance Associate III- Gene Therapy
Janssen Pharmaceuticals, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate III . The position will be based in Malvern, PA or Spring House, PA.
The role of Quality Assurance Associate III provides oversight for activities related to the PDMS (Research and Clinical Development) and Gene/Cell Therapy organizations in the US to ensure non-conformances are investigated thoroughly and approved in a timely manner, and appropriate corrective and preventive action plans are implemented in compliance with applicable regulations, policies, SOPs, and guidelines. Associate will be instrumental in helping to build quality systems and SOPs/MBRs for a sterile processing clinical production facility. Additionally, this position provides compliance oversight for review of all documentation and reporting in support of development and validation processes within the supported organizations. Performs inspection readiness activities to ensure compliance with cGMPs and applicable SOPs and guidelines. Strives to reduce non-conformances in supported areas by proactively driving compliance. Provides support during internal audits and regulatory inspections. Will act as a single point of contact from a quality perspective in helping to design quality systems and provide robust guidance to design and support a clinical manufacture facility through creation of all new documents to support production.
Responsibilities will include but are not limited to:
- Reviews site operation and validation documents to ensure compliance. Documents may include: all production area SOPs; Specifications; MBRs; Mechanical and Automation documents; Commissioning and Design documents; process validations; calibration and maintenance procedures; analytical methods; technical studies; trending reports, transfer reports, summary reports and change controls.
- Reviews and approves CAPAs and non-conformances associated with Validation Execution, Analytical Development, and manufacturing/ facility issues.
- Ensures CAPA and non-conformances meet established standards and regulations.
- Ensures effective and timely closure of CAPAs and non-conformances, and follows up to ensure effectiveness of corrective actions.
- Analyzes compliance issues and trends to improve quality systems and overall compliance.
- Initiates and or approves changes to processes or systems to enhance compliance relative to FDA and ICH regulations and Janssen standards.
- Acts as subject matter expert to customers, providing input on site-specific quality and compliance issues related to PDMS.
- Ensures customers are educated on quality requirements. Provides quality input on a variety of issues.
- Represents QA on project teams, cross-functional teams and multi-site teams, as requested. Drafts, reviews and approves SOPs, as necessary.
- Supports internal and external audits/site inspections for GMP regulated activities. Provides Change Control guidance/oversight by working with Change Control authors and impacted sites.
- Provides input/assessments for implementation plan execution when necessary. Reviews and approves change controls related to PDMS manufacturing, laboratory and facility systems.
- Ensures effective and timely closure of Change Controls, and follows up to ensure effectiveness of the changes. In support of Maintenance program, consults on: work requests, work orders, calibration extensions and change requests, corrective and/or preventive maintenance.
Additional responsibilities may include: Liaisons with other quality organizations and PDMS sites to harmonize policies, practices and procedures to increase quality and compliance and to cultivate increased awareness of quality related concerns.
- Works with customers to troubleshoot issues, identifying and resolving root causes.
- Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
- Complies with all company and site policies and procedures.
- Successfully completes regulatory and job training requirements.
- Makes a positive contribution as demonstrated by: makes suggestions for improvement; provides overtime as needed; learns new skills, procedures and processes.
- Remains current in skills and industry trends. Is available for other duties as required.
- A minimum of a Bachelor's Degree in Engineering, Science or equivalent technical discipline is required.
- A minimum of 4 years of experience in Quality Assurance related to manufacturing is required.
- Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is required.
- A minimum of 2 years of experience with quality support in clinical manufacture or NPI is preferred.
- Additionally, knowledge and application of sterile processing is required.
- A minimum of 2 years with knowledge of pharmaceutical quality systems is required.
- Knowledge of current U.S. and EU cGMP's/regulatory requirements, related to QA is preferred, as well as knowledge of Good Tissue Practices.
- Ability to write, read, comprehend, analyze, or interpret instructions, business, professional, scientific, technical and governmental documentation, journals, SOPs and regulations are preferred.
- Strong organizational, communication, and project management skills are required. Must be able to work independently to meet project deliverables.
- The position can be based in Spring House, PA or Malvern, PA and may require up to 50% local travel, depending on the location of the role.
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.
North America-United States-Pennsylvania-Spring House
JANSSEN SUPPLY GROUP, LLC (6046)
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