Hybrid QA Associate III

at Johnson & Johnson

• Job title: QA Associate III
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Malvern, United States

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