QA Specialist I Doc Control

JOB REQUIREMENTS: Life changing therapies. Global impact. Bridge tothousands of biopharma companies and their patients. We are PCI. Ourinvestment is in People who make an impact, drive progress and create abetter tomorrow. Our strategy includes building teams across our globalnetwork to pioneer and shape the future of PCI. The Document ControlSpecialist will manage and coordinate critical cGMP documentation,procedures, and records that keep our operations compliant andaudit-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 drivingprocess improvements, supporting audits, and collaborating withcross-functional teams. What You'll Do Maintain quality systemdatabases, master documents, and numbering logs. Issue, archive, andmanage controlled records (Batch Records, Lab Books, Log Books, TestingData Sheets, etc.). Facilitate batch record creation, modifications, andapprovals for client projects. Lead SOP lifecycle management includingbiennial reviews, updates, and obsoleting outdated versions. Write anddevelop QA SOPs; implement new systems for document control with minimalsupervision. Proof, edit, and process document changes. Assist withaudit preparation, reconciliation, and line clearances (as needed).Support training and presentations related to document controlprocesses. What We're Looking For Experience: High School/Associatedegree with 10+ years in a cGMP environment, OR Bachelor's degree with5-10 years of relevant experience in pharma/biotech manufacturing.Skills: Strong organizational abilities, MS Office proficiency,excellent written/verbal communication, and comfort working with SOPsand spreadsheets. Attributes: Detail-oriented, adaptable, and able tothrive in a fast-paced, team-oriented environment. Bonus: Priorpharmaceutical GMP experience and experience supporting audits. #LI-LL1Join us and be part of building the bridge between life changingtherapies and patients. Let's talk future Equal Employment Opportunity(EEO) Statement: PCI Pharma Services is an Equal Opportunity/AffirmativeAction Employer. We do not unlawfully discriminate on the basis of race,color, religion, age, sex, creed, national origin, ancestry, citizenshipstatus, marital or domestic or civil union status, familial status,affectional or sexual... For full info follow application link. LSNE isan EEO/AA Employer and all qualified applicants will receiveconsideration for employment without regard to, their race, color,religion, sex, age, national origin, ancestry, sexual orientation,gender identity, disability, protected genetic information, protectedveteran status, military service, or other protected status. TheCompany's EEO policy, as well as its affirmative action obligations,include the full and complete support of The Company. APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/736A2ED8A6734531

Created: 2025-09-12