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 QA Specialist I -Doc Control will manage, coordinate, and maintain CGMP documentation,procedures, and records to ensure only controlled copies are reviewed,approved, issued, distributed, and archived. Essential Duties andResponsibilities: To perform this job successfully, an individual mustbe able to perform each essential duty satisfactorily. The essentialduties and responsibilities include the following but other duties maybe assigned. . Maintain DCR/Quality system event databases and MasterDocuments / List Maintain Designated Satellite Areas for controlledpaper based record management system Create Labels as needed Facilitate Client Batch Record Creation / Modifications / Approvals Issue and Archive Batch Records / Testing Data Capture Sheets / LabBooks / Equipment Log Books / Room Log Books/Quality system eventdocuments Facilitate Biennial SOP reviews Maintain Document /Material / Batch Numbering Logs Obsolete Documents Writes anddevelops QA SOPs under minimal supervision IndependentlyDevelops/implements new systems for Document control under minimalsupervision Manage Record / Document Filing system Proof and editdocument changes including minor SOP updates, if necessary Assistwith Line Clearances (Backup capacity) Assist in audit preparationand reconciliation Other duties as assigned Special Demands: Thephysical demands described here are representative of those that must bemet by an employee to successfully perform the essential functions ofthis job. The employee must be physically capable to perform the dutieslisted below with or without reasonable accommodations which may be madeto enable individuals with disabilities to perform the essentialfunctions. Requires the ability to communicate effectively usingspeech, vision, hearing and written word Requires bending, squatting,climbing, reaching Requires the ability to lift, carry, push or pulllight weights (up to 20 pounds) Work Environment: The work environmentcharacteristics described here are representative of those an employeeencounters while performing the essential functions of... For full infofollow application link. LSNE is an EEO/AA Employer and all qualifiedapplicants will receive consideration for employment without regard to,their race, color, religion, sex, age, national origin, ancestry, sexualorientation, gender identity, disability, protected genetic information,protected veteran status, military service, or other protected status.The Company's EEO policy, as well as its affirmative actionobligations, include the full and complete support of The Company. APPLICATION INSTRUCTIONS: Apply Online:ipc.us/t/4AF61B833D0F467F

Created: 2025-12-18