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.
Job Title:
Quality Assurance Specialist – 3rd Party Products
Department:
Clinical Quality
Division / Section:
Quality Assurance
Accountable to:
Qualified Person /
Accountable for:
(people manager)
N/A
Summary of Role
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
Part of the Batch File Review Team who:
Compile batch documents
Review batch documents in advance of QP review.
Review analytical data.
Work with responsible site to complete corrections
Prepare Certificate of Compliance for QP.
Work closely with QP as issues arise and find resolution
Review of regulatory documentation and liases with Regulatory compliance team to trouble shoot issues.
Perform a batch file review for batches manufactured/packed at PCI or in third party company.
Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
Coordination of every product supply chain flow – products which are coming from rest of the world and releasing to the European Union
Participating customer meetings – discussion/collection/summary about the necessary quality documentation
Writing SOPs or Work Instructions
Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Knowledge / Skills & Experience
Essential:
Degree and/or relevant experience.
5 years of Quality experience.
Experience of working in a GMP environment.
Good communication skills.
Steriles experience is desirable.
Ability to problem solve.
· Capability to set clear goals, communicate these clearly and ensure progress to completion/meeting predefined targets.
· Proven track record of showing how results were delivered through management/leadership of others.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
· Team player
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.
PCI Pharma Services Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.
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Retirement Support — Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
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Leave & Time Off Breadth — PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
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Affordable Benefits — Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.
PCI Pharma Services Insights
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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.
