Associate Manager, QA Shop Floor

Role Overview

The Associate Manager, QA Shop Floor is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes supervision of QA shop floor personnel as well as working with manufacturing to troubleshoot issues.

• Read, interpret, and revise documents such as SOPs, work instructions.
• Develop positive relationships with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers.
• Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel.
• Independently make appropriate and compliant GMP decisions.
• Independently resolve problems using quality systems.
• Lead quality driven continuous improvement projects.
• Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
• Support QASF team growth and development.
• Must be able to be Aseptic Gown Qualified.
• Possess the ability to positively influence peers, key stakeholders, and management.
• Generates shift schedules, to ensure efficient coverage for all operational needs.
• Maintain quality practices in accordance with state and federal regulatory requirements.
• Supports the completion of corrective and preventive actions, as necessary.
• Supports internal/external audits.
• Supports Quality risk assessment teams.
• Review/approve documents as a Quality on the Floor Subject Matter Expert (SME).
• Remain current in skills and industry trends.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.
• Color perception both eyes 5 slides out of 8.

• Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
• Experience in a Quality Control setting is preferred.
• Experience with processing samples in biosafety cabinets utilizing aseptic technique is strongly preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is strongly preferred.
• Knowledge of Good Tissue Practices is required.
• Knowledge of CAR-T QC test methods and related equipment is preferred.
• Excellent written and oral communication skills are required.
• Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Comfortable with speaking and interacting with regulatory inspectors.
• This position may require occasional travel to partner sites in NJ or PA as business demands.
• This position may require up to 5% domestic or international travel as business demands.
• Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.
• Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.
• Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent.
• Identifies and focuses on activities of highest value and impact; makes informed decisions quickly.
• Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency.
• Considers resources, alternatives, constraints and desired outcomes to make effective decisions.
• Employs good project management principles to appropriately align time, resources, and budgets.
• Appreciates diverse perspectives and is actively…