QA Specialist I - Doc Control
About The Position
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 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 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.
Requirements
- Exceptional Organizational Skills
- Competent in MS Office
- Professional Verbal and Written Communication Skills Required
- Data Processing, Spreadsheets, SOP Generation
- Prior GMP experience preferably in a the pharmaceutical manufacturing industry
- High School Diploma/associates degree with a Minimum of ten years in a cGMP Environment; 5-10 year previous experience with Bachelor’s degree
- Detail Oriented
- Strong multitasker who is comfortable working in a fast paced
- Team oriented and strong collaborative approach to work
Responsibilities
- Maintain DCR/Quality system event databases and Master Documents / List
- Maintain Designated Satellite Areas for controlled paper based record management system
- Create Labels as needed
- Facilitate Client Batch Record Creation / Modifications / Approvals
- Issue and Archive Batch Records / Testing Data Capture Sheets / Lab Books / Equipment Log Books / Room Log Books/Quality system event documents
- Facilitate Biennial SOP reviews
- Maintain Document / Material / Batch Numbering Logs
- Obsolete Documents
- Writes and develops QA SOPs under minimal supervision
- Independently Develops/implements new systems for Document control under minimal supervision
- Manage Record / Document Filing system
- Proof and edit document changes including minor SOP updates, if necessary
- Assist with Line Clearances (Backup capacity)
- Assist in audit preparation and reconciliation
- Other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
