QA Operations Specialist - Floor Support

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

• Perform QA on-the-floor activities supporting client projects, including room release, auditing critical processes, reviewing GMP documentation in real time.
• Perform periodic walkthroughs of manufacturing and support areas to ensure adherence to policies and procedures.
• Batch record review for adherence to internal procedures and Good Documentation Practices
• Review, approval and disposition of incoming materials such as consumables, excipients, and bulk device Ingredient, as applicable.
• QA review and approval of new and revised GMP documents such as SOP’s and raw material specifications.
• Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
• Assist in nonconforming material investigations.
• Review of Quality Control Environmental Data
• Review and approval of work orders impacting manufacturing facilities and utilities
• May participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc.
• Advise and coach internal customers on proper documentation of tasks
• Assist in the initiation of Quality Systems (deviations, CAPA, Nonconformances).
• Support Visual Inspection, packaging, and labeling operations
• Create, review, and approve final product labels
• Participate in SOP revision as it pertains to process improvements.
• Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.
• Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices
  
  

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.