Quality Assurance Manager

4 weeks ago


Madison, Wisconsin, United States PCI Pharma Services Full time

Job Summary:

The QA Manager will oversee the daily functions of the quality system, ensuring compliance with FDA regulations and company standards. This role requires strong leadership and organizational skills, as well as excellent communication and problem-solving abilities.

Key Responsibilities:

  • Directly supervise Documentation Control, QA Associates, and Trainer, and act as backup and support to their activities.
  • Work directly with the Sr. Director, Quality on continuous improvement activities.
  • Ensure client specifications are met during materials receipt, Drug/Device processing, and final product shipment.
  • Review and approval of Validation Protocols (master and final reports).
  • Approval of Deviations and CAPAs.
  • Responsible for Environmental Monitoring and WaterTrend Reports.
  • Provide QA Staff support (and backup) including scheduling updates and assignment of duties.
  • Documentation Control prioritization: document processing, batch record issuance, change control issuance.
  • Training: issuing notifications for training needs, maintenance of training files, initiating core training for new employees, present training to personnel as needed.
  • Operations: provide line clearances and documentation as needed.
  • Product and Materials Records Review: batch record review and release, materials review and approval, including calibration, water testing, environmental monitoring, temperature and humidity review.

Requirements:

  • University degree in a related science discipline with 7 to 10 years experience in an FDA regulated Pharma or Biotech industry.
  • Prior supervisory experience.
  • Excellent organizational skills, strong oral and written communication skills, detail-oriented, ability to multi-task, flexibility required.
  • Computer skills (Excel, Word, Access, and PowerPoint).

About PCI Pharma Services:

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled. 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.

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience.

Our people make all of this happen, so providing an industry leading experience for our people is equally as important.

By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers.

We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program.

We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.



  • Madison, Wisconsin, United States CorVel Healthcare Corporation Full time

    Job DescriptionCorVel Healthcare Corporation is seeking a Quality Assurance Nurse to conduct utilization review and case management quality assurance audits. The ideal candidate will have experience in worker's compensation and a strong understanding of clinical and case management processes.Key Responsibilities:Develop and implement quality assurance...


  • Madison, Wisconsin, United States Payne & Dolan Full time

    Job Title: Quality Assurance SpecialistJob Summary: We are seeking a Quality Assurance Specialist to join our team at Payne + Dolan, Inc. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our construction projects.Responsibilities:Conduct quality control inspections on construction sitesIdentify and report any quality...


  • Madison, Wisconsin, United States GE Healthcare Full time

    Job Summary:This role is responsible for driving exceptional product quality for patient safety, customer value, regulatory assurance, and optimized Cost of Quality for GEHC.This is a key technical position, affecting part quality for the installed base.Key Responsibilities:Improve supplier quality performance by sending timely defect data.Assure supplier...


  • Madison, Wisconsin, United States Just Breathe Massage Therapy Full time

    We are seeking a skilled Quality Assurance Specialist to join our team at "{company}". As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services. This includes conducting regular audits, identifying areas for improvement, and implementing corrective actions.Key Responsibilities:Conduct regular quality...


  • Madison, Wisconsin, United States Octopi Brewing Full time

    Job Summary:The Quality Assurance (QA) Technician will be responsible for maintaining quality throughout the plant and in all processes. This includes performing physical, chemical, and microbiological tests, sampling product from several points during production, managing documentation and data associated with those tests/samples, and maintaining equipment...


  • Madison, Wisconsin, United States Octopi Brewing Full time

    About Quality Technician Role at Octopi Brewing:We are seeking a detail-oriented Quality Assurance (QA) Technician to perform checks and tests to maintain quality throughout the plant and in all processes. As a Quality Technician, you will be responsible for daily sampling and testing of in-process and finished product, including tasks like inspecting...


  • Madison, Wisconsin, United States ExamWorks Full time

    At ExamWorks, we are seeking a highly skilled Clinical Quality Assurance Coordinator to join our team. This role is responsible for ensuring Peer Review case reports are of the highest quality and integrity and in full compliance with client contractual agreement, regulatory agency standards and/or federal and state mandates.Responsibilities:Performs quality...


  • Madison, Wisconsin, United States Bristol-Myers Squibb Full time

    Job SummaryAs a Research Quality Assurance Intern at Bristol-Myers Squibb, you will have the opportunity to work in a dynamic and innovative environment where you will be responsible for ensuring the quality of our research and development processes. You will work closely with our quality assurance team to identify and mitigate potential quality risks, and...


  • Madison, Wisconsin, United States Argus Technical Services Full time

    We are seeking a seasoned Senior Pharmaceutical Quality Assurance Lead to join our team at Argus Technical Services in Omaha, NE. This rare opportunity to relocate and work with a dynamic company offers a unique chance to grow professionally and personally.The Senior Pharmaceutical Quality Assurance Lead will be responsible for managing operational quality...


  • Madison, Wisconsin, United States PCI Pharma Services Full time

    Job Summary:The QA Manager is responsible for overseeing the daily functions of the quality system at PCI Pharma Services. This includes direct supervision of Documentation Control, QA Associates, and Trainer, as well as backup and support for their activities.Key Responsibilities:Work directly with the Sr. Director, Quality on continuous improvement...


  • Madison, Wisconsin, United States PCI Pharma Services Full time

    Job Summary:The QA Manager is responsible for overseeing the daily functions of the quality system, ensuring compliance with regulatory requirements and company policies. This role involves direct supervision of Documentation Control, QA Associates, and Trainer, as well as backup and support for their activities.Key Responsibilities:Work directly with the...


  • Madison, Wisconsin, United States Chili's Grill & Bar Full time

    Quality Assurance SpecialistAt Chili's Grill & Bar, we're looking for a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring that every Guest receives perfectly prepared, high-quality food. This involves controlling the pace of food orders, following company safety and sanitation...


  • Madison, Wisconsin, United States IGT Full time

    Job Summary:IGT is a global leader in gaming, delivering entertaining and responsible gaming experiences for players across all channels and regulated segments. We are seeking a skilled Software Quality Assurance Engineer III to join our team. The ideal candidate will have a strong understanding of the software development life cycle and methodologies, with...


  • Madison, Wisconsin, United States Accuray Full time

    Job Summary:The Supplier Quality Engineer is a key member of the Quality Assurance team at Accuray, responsible for planning and executing activities related to the selection, monitoring, and control of purchased materials and suppliers.This role involves working cross-functionally with engineering, procurement, manufacturing, service, and other quality...


  • Madison, Wisconsin, United States Gpac Full time

    Quality Supervisor OpportunityGpac, an award-winning search firm, is seeking an exceptional Quality Supervisor to contribute to the company's growth and development.Key Responsibilities:Lead Team: Coach and mentor team members to success, promoting a culture of excellence and continuous improvement.Quality Problem Identification: Develop and implement a...


  • Madison, Wisconsin, United States Sub-Zero & Wolf Appliance Full time

    The Supplier Quality Engineering team plays a vital role in ensuring the quality and integrity of materials and components used in our luxurious products.This position will join a team of experienced engineers who are dedicated to promoting continuous improvement and supporting departmental goals.The team is responsible for developing and implementing...


  • Madison, Wisconsin, United States Manitou Madison SD Full time

    Job DescriptionAs a key member of the Manitou Madison SD team, the Pre-Delivery Inspector will be responsible for ensuring the quality of our finished machines prior to shipping. This involves inspecting machines against documented acceptance criteria and typical market standards, as well as performing minor rework as required.Key Responsibilities:Evaluate...


  • Madison, Wisconsin, United States IGT Full time

    Job Summary:IGT is seeking a highly skilled Software Quality Assurance Engineer III to join our team. As a key member of our QA team, you will be responsible for generating test documentation, executing tests, and providing project reports. You will work independently and be the primary contact with development services. Your duties will include organizing,...


  • Madison, Wisconsin, United States CapB InfoteK Full time

    About the Role:CapB InfoteK is a global leader in IT Solutions and Managed Services, with a focus on providing cutting-edge products and solutions across digital transformations. We are seeking a skilled Test Specialist to join our team and contribute to our growing needs.Key Responsibilities:Work with our R&D team to develop and implement automated testing...


  • Madison, Wisconsin, United States Ampersand Solutions Group Full time

    Ampersand Solutions Group is seeking a highly skilled Staff Software Quality Assurance Engineer to join our team. The ideal candidate will have a strong background in software testing and validation, with a minimum of 5 years of experience in regression testing and performance testing. The selected candidate will be responsible for developing and managing...