Production Supervisor

PCI Pharma Services; Philadelphia (Philadelphia County); On-site; USD 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Assurance Associate to ensure compliance with cGMP standards in pharmaceutical packaging. This role involves auditing production documentation, conducting equipment checks, and ensuring that all processes meet stringent quality requirements. The ideal candidate will possess strong analytical and communication skills, and a commitment to safety and quality improvements. Join this forward-thinking organization to play a vital role in bridging therapies and patients while working in a dynamic environment that values your contributions and growth.

Qualifications

• 2-4 years of relevant experience in production or process, preferably in pharmaceuticals.
• Strong analytical and communication skills are essential.

Responsibilities

• Audit production documentation and ensure compliance with cGMP standards.
• Review batch records and lead quality improvements.

Skills

Analytical Skills

Communication Skills

Interpersonal Skills

Detail-oriented

Knowledge of cGMP documentation

Education

High School Diploma

Tools

MS Office

Lotus Notes

ERP systems

Job description

Job Description: Quality Assurance Associate in Pharmaceutical Packaging

We are PCI, committed to life-changing therapies with a global impact. Our focus is on building teams across our network to pioneer and shape the future of PCI.

This role supports the organization, monitoring, and compliance of cGMP standards to ensure the successful, cost-effective, and timely packaging of customer orders. Responsibilities include auditing production documentation, equipment checks, in-process inspections, and ensuring samples and AQL requirements are met. The associate will review batch records, co-sign during batch processing, and lead continuous quality and process improvements through mentoring and training.

Key Responsibilities:

1. Approve production room operations post product and lot changes.
2. Verify first piece inspection for correctness of finished goods code, format, and expiration date.
3. Ensure packaging within validated parameters and equipment calibration is within specifications; coordinate recalibration if needed.
4. Review batch records for equipment challenges and inspections, addressing non-conformances.
5. Ensure proper sampling documentation and labeling.
6. Audit production logs for accuracy and timeliness.
7. Check cleaning and maintenance logs, ensure proper documentation.
8. Audit safety compliance among production personnel.
9. Maintain segregation of recovery stations from product flow.
10. Verify correctness of bulk materials and components.
11. Review clean room logs for completeness and accuracy.
12. Monitor environmental data such as temperature and humidity.
13. Identify gaps in documentation, participate in improvement teams, and support root cause analysis.
14. Support end-of-shift batch review and quality documentation.
15. Report quality issues to management.
16. Create labels and serve as SME for JDE transactions on the floor.
17. Perform other duties as assigned, including potential overtime and weekend work.

Qualifications:

• High School Diploma required; 2-4 years of relevant experience in production or process, preferably in pharmaceutical, biopharmaceutical, or medical device sectors.
• Strong analytical, communication, and interpersonal skills.
• Dependability, initiative for safety and quality improvements, and flexibility across shifts.
• Detail-oriented with knowledge of cGMP documentation.
• Proficient in MS Office, Lotus Notes, spreadsheets, and ERP systems.

Physical & Work Environment:

Must be physically capable of performing essential duties, including lifting up to 50 pounds, with or without accommodations. The work environment is moderate noise, with frequent walking, standing, and occasional sitting.

Join us to build the bridge between therapies and patients. Let's talk future.

EEO Statement:

PCI Pharma Services is an Equal Opportunity Employer committed to fostering an inclusive workplace where everyone can belong and grow.