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 QA Manager is responsible for oversight of all daily functions of the quality system. Directly Supervise Documentation Control, QA Associates and Trainer, and act as backup and support to their activities.
Essential Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- Work directly with the Sr. Director, Quality on continuous improvement activities.
- Responsible for ensuring that client specifications are met during materials receipt, Drug / Device processing and final product shipment.
- Responsible for ensuring that procedures are followed and quality standards are met.
- Works directly with the Sr VP of Quality to evaluate products and materials for compliance to specifications.
- Oversight for established quality systems (Document Control, CAPA, Deviation, Environmental Monitoring, Change Control, Complaint, Calibration, Documentation, Training, Component Control, Batch Record Review, Label Control, Product Release).
- Review/approval of Validation Protocols (master and final reports).
- Approval of Deviations and CAPAs.
- Responsible for Environmental Monitoring and WaterTrend Reports.
- Provide QA Staff support (and backup) including:
- Scheduling updates and assignment of duties.
- Documentation Control prioritization: document processing, batch record issuance, change control issuance.
- Training: issuing notifications for training needs, maintenance of training files, initiating core training for new employees, present training to personnel as needed.
- Operations: provide line clearances and documentation as needed.
- Product and Materials Records Review: batch record review and release, materials review and approval, including - calibration, water testing, environmental monitoring, temperature and humidity review.
Work Environment:
- Work is primarily performed at a desk and/or in an office environment. for 1/2 to 3/4 of the day.
Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Educational and Professional Experience:
- University degree in a related science discipline with 7 to 10 years experience in an FDA regulated Pharma or Biotech industry.
- Must have prior supervisory experience.
Personal Skills & Competencies:
- Excellent organizational skills required.
- Strong oral and written communication skills required.
- Detail oriented.
- Ability to multi-task, flexibility is required.
- Computer skills (Excel, Word, Access, and PowerPoint)
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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, Diversity, Equity, and Inclusion (DEI) 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.
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What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
