SDO_Lead, Quality Inspection

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.

The Quality Control Lead supports PCI QC Inspection processes for incoming GMP materials, and shipping operations. This position will focus on the oversight of the QC inspection of incoming materials inspection activities and distribution activities. In addition, the person may assist with document control activities and product lot disposition.

Role and responsiblities

Perform QC line clearance verification, in-process checks and monitoring of distribution activities on the floor. Perform QC inspection of incoming GMP materials according to appropriate material specifications Perform and assist product lot disposition by reviewing receiving documents for completeness, accuracy, and compliance to GMP and company procedures. Assist document change control activities as needed. Support shipping operations, on as needed basis. Perform document change control activities as needed. Perform and lead in investigations, NCMRs and Complaints. Track and monitor CAPAs. Perform training as needed. Support Distribution activities. Collect Quality Metrics. Support the Quality Supervisor with internal, supplier, regulatory and customer audits. Perform QC line clearances, in-process checks and monitoring of labeling and packaging activities on the floor. Perform QC inspection or release of incoming GMP materials according to appropriate material specifications Ensure department and company goals are met. May perform other department tasks.

minimum education and experience requirements

• HS diploma or a college degree.
• Minimum of 5-10 years of experience in the pharmaceutical/biotech/medical device industry.
• Direct experience in cGMP environment required.
• Experience with clinical study labeling and packaging is a plus.
• Position requires working independently with minimal supervision and the ability to effectively work with other departments

NOTE:      This job description is not intended to be all-inclusive. It is intended to describe the general nature of the job which may include other related duties as negotiated to meet the ongoing needs of the organization.

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.