Supervisor, Quality Assurance Internal Operations Job at PCI Pharma Services (Madison)

Job Description

Responsible for leading QA Associates, who provide QA support in the manufacturing of clinical and commercial drug products, to ensure compliance with the principles and guidelines of cGMP. The Supervisor, QA Ops assists in maintaining quality systems, management of investigations, materials management and providing QA support in real time for manufacturing, to ensure control of the manufacturing process. This position will actively partner with Manufacturing Operations, Facilities, Materials Management, and other supporting departments to provide compliance and technical guidance to ensure quality issues are identified and resolved in a timely manner.

Job Responsibility

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
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

Requirements

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

Nice to have

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

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Supervisor, Quality Assurance Internal Operations

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