Associate Software Quality Assurance Engineer Jobs in Madison, WI

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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.

Essential Duties and 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 projectmanagement deliverables, and reviewing factors that may impact schedules.
• Oversee Quality System Events (QSEs) by verifying a Quality reviewer has been assigned to the QSE andmonitor 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.

Qualifications:

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 environmentpreferred.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.