PCI Pharma Services · 5 days ago
QA Associate I - Operations
Madison, WI
Full-time
Onsite
New Grad, Entry Level
0+ years expPCI Pharma Services is a company focused on life-changing therapies and global impact. They are seeking a Quality Associate I – Operations to provide real-time quality oversight in GMP production, ensuring product safety and compliance while receiving hands-on training and mentorship.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Provide real-time QA support on the production floor: observe critical operations, audit procedures, and monitor compliance during GMP manufacturing
Perform in-process reviews of executed batch records and documentation for completeness and accuracy
Participate in lot disposition and review of drug product and intermediates
Act as a first responder to quality issues, documenting investigations and supporting immediate corrective actions
Conduct Acceptable Quality Limit (AQL) visual inspections of drug product
Support deviation documentation, root cause investigations (using tools like 5 Whys, Fishbone), and CAPA processes
Collaborate across departments and represent QA during manufacturing activities and process improvements
Contribute to SOP revisions, quality initiatives, and regulatory readiness
Qualification
Required
Bachelor's degree in a relevant scientific field (preferred)
0–2 years of experience in the pharmaceutical or biotech industry
Understanding of GMP regulations (21 CFR 210/211/820); exposure to ICH guidelines and risk tools (FMEA, HACCP, ICH Q9) a plus
Strong organizational and technical writing skills, with attention to detail
Familiarity with Microsoft Word, Excel, and Outlook
Ability to manage multiple tasks and communicate effectively across teams
Self-starter mindset with the ability to work independently and escalate issues appropriately
Flexible and adaptable to fast-paced, evolving environments
Preferred
1+ years of experience in QA Operations (preferred)
ASQ certification
Exposure to Lean/Operational Excellence methodologies
Experience supporting commercial or late-stage clinical GMP operations
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