PCI Pharma Services · 15 hours ago
QA Specialist I - Doc Control
Madison, WI
Full-time
Onsite
Senior Level
5+ years expPCI Pharma Services is a company focused on life-changing therapies and global impact. The QA Specialist I - Doc Control will manage and maintain CGMP documentation and procedures to ensure compliance and proper documentation control.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
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
Qualification
Required
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
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase