PCI Pharma Services · 3 months ago
Supervisor, Quality Assurance Internal Operations
Madison, WI, USA
Full-time
Onsite
Senior Level
5+ years expPCI Pharma Services is a company dedicated to bridging life-changing therapies to patients. The Supervisor, Quality Assurance Internal Operations is responsible for leading QA Associates in providing support for cGMP manufacturing operations, ensuring compliance, and overseeing quality system events.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Provide QA support for cGMP manufacturing operations
Coordinate with cross-functional teams to continually improve procedures with respect to area line clearances, labeling, packaging and material release
Support QA scheduling activities by monitoring the production, and visual inspection schedules and project management deliverables, and reviewing factors that may impact schedules
Oversee Quality System Events (QSEs) by verifying a Quality reviewer has been assigned to the QSE and monitor that the QSEs are being completed on time. Assist where needed
Lead Associates in providing QA on the floor oversight of manufacturing
Oversee and assist employees with product / material labeling and disposition functions, routine manufacturing area line clearances, AQL Sampling and Inspection of Final Package Lots
Supervise the employees in the Quality Assurance Department
Ensure all training is performed by employees, including aseptic gowning, facility flow and visual inspection
Maintain Quality Metrics for the company
Review of master and executed raw material records. Release raw materials, as necessary
Review of associated QC data to support facility and products, as applicable
Review Quality logbooks, as applicable
Responsible for writing and revising Standard Operating Procedures, specifications, material control procedures, deviations, CAPA’s, and Quality Investigations when applicable
Direct involvement in supporting external client audits at PCI and regulatory inspections, and responsible for responding to audit observations, as applicable
Obtain gown qualification for sterile manufacturing line clears
Assist with Change Control, as needed
Maintain and evaluate procedures and monitor new regulations
This position may require overtime and/or weekend work
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor
Qualification
Required
BS degree in a scientific discipline
Minimum 5+ year's relevant GMP experience
Knowledge of FDA/ISO regulatory requirements as well as industry trends
Computer knowledge, including Microsoft Office, Windows
Excellent interpersonal skills, must be able to lead and make decisions
College Level Mathematical Skills
Preferred
Experience supporting manufacturing and conducting training is preferred
Previous supervisory experience is preferred
Experience executing GMP quality systems in a pharmaceutical/biotech/medical device environment preferred
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