Quality Assurance Coordinator supporting Supply Chain Logistics in contact lens production. Ensuring quality standards compliance and managing quality documentation in the European Distribution Center.
About the role
- QA Associate III ensuring quality compliance for biotherapeutic product testing. Collaborating with R&D and Supply Chain teams for analytical processes and laboratory oversight.
Responsibilities
- Partner with Research & Development and Supply Chain teams to support platform analytical method qualification, validation, and transfer to facilitate analysis of pre-clinical, clinical, and commercial products.
- Collaborate with business partners to support process development studies.
- Perform regularly scheduled oversight of R&D GxP laboratories.
- Review and approve raw material and critical reagent release for use across the Janssen global network.
- Review and approve controlled documents including standard operating procedures, work instructions, validation protocols and reports, and technical studies.
- Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
- Support change management processes including formal change controls by evaluating proposed changes, assessing impact, and providing quality input on implementation plans.
- Provide quality oversight of the analytical instrument lifecycle management process, including new instrument qualification, equipment releases, corrective and preventative maintenance and calibrations.
- Ensure data integrity and maintain compliance with general laboratory operations, all appropriate SOPs for laboratory work, data recording, and laboratory equipment.
- Lead in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.
- Support site inspections and inspection readiness activities.
- Ensure the laboratories are audit ready.
- Support data integrity efforts.
Requirements
- A minimum of a Bachelor’s Degree in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field.
- At least 4 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
- Ability to maintain written records of work performed in paper-based and computerized quality systems.
- Ability to work independently on complex issues with minimal supervision.
- Ability to be organized and capable of working in a team environment with a positive demeanor.
- A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
- Solid Understanding of cGMP regulations and FDA/EU guidance related to biologics or advanced therapies.
- Experience in automated laboratory systems and warehouse/raw material sampling and receipt preferred.
- Experience with quality support in clinical/GMP manufacturing or support of GXP laboratories is preferred.
- Working knowledge of GLP regulations preferred.
- Experience working with CMMS Systems like SAP and Maximo, and electronic laboratory notebook systems (Biovia, eLIMS) is preferred.
- Experience performing and leading quality risk assessments for business processes is preferred.
- Experience with document reviews and regulatory inspection processes is preferred.
- Ability to prioritize daily business needs while being flexible and adaptable to frequently shifting priorities.
Benefits
- Health insurance
- Professional development opportunities
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