QA Specialist I - Doc Control

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 Document Control Specialist will manage and coordinate critical cGMP documentation, procedures, and records that keep our operations compliant and audit-ready.

In this role, you'll be at the heart of Quality Assurance, ensuring controlled documents are properly reviewed, approved, issued, distributed, and archived. You'll also play a key role in driving process improvements, supporting audits, and collaborating with cross-functional teams.

What You'll Do

• Maintain quality system databases, master documents, and numbering logs.

• Issue, archive, and manage controlled records (Batch Records, Lab Books, Log Books, Testing Data Sheets, etc.).

• Facilitate batch record creation, modifications, and approvals for client projects.

• Lead SOP lifecycle management including biennial reviews, updates, and obsoleting outdated versions.

• Write and develop QA SOPs; implement new systems for document control with minimal supervision.

• Proof, edit, and process document changes.

• Assist with audit preparation, reconciliation, and line clearances (as needed).

• Support training and presentations related to document control processes.

What We're Looking For

• Experience:

  • High School/Associate degree with 10+ years in a cGMP environment, OR

  • Bachelor's degree with 5-10 years of relevant experience in pharma/biotech manufacturing.

• Skills: Strong organizational abilities, MS Office proficiency, excellent written/verbal communication, and comfort working with SOPs and spreadsheets.

• Attributes: Detail-oriented, adaptable, and able to thrive in a fast-paced, team-oriented environment.

• Bonus: Prior pharmaceutical GMP experience and experience supporting audits.

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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.