Quality Assurance Manager

4 days ago


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 activities.
  • Ensure client specifications are met during materials receipt, Drug/Device processing, and final product shipment.
  • Ensure procedures are followed and quality standards are met.
  • Collaborate with the Sr. VP of Quality to evaluate products and materials for compliance to specifications.
  • Oversight of established quality systems, including Document Control, CAPA, Deviation, Environmental Monitoring, Change Control, Complaint, Calibration, Documentation, Training, Component Control, Batch Record Review, Label Control, and Product Release.
  • 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, including scheduling updates and assignment of duties.
  • Documentation Control prioritization, including document processing, batch record issuance, and change control issuance.
  • Training, including issuing notifications for training needs, maintenance of training files, and initiating core training for new employees.
  • Operations, including providing line clearances and documentation as needed.
  • Product and Materials Records Review, including batch record review and release, materials review and approval, and calibration, water testing, environmental monitoring, temperature, and humidity review.

Requirements:

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



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

    Job Title: Quality Assurance ManagerAt PCI Pharma Services, we are committed to delivering life-changing therapies to patients worldwide. As a Quality Assurance Manager, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Oversee the daily functions of the quality system, including documentation control,...


  • Madison, Wisconsin, United States HR Now Talent Network Full time

    Job Title: Quality Assurance ManagerWe are seeking an experienced Quality Assurance Manager to join our team at HR Now Talent Network. This role is crucial in maintaining the highest standards of safety, quality, and operational efficiency in a fast-paced production environment.Key Responsibilities:Safeguard consumer and employee safety while upholding brand...


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

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at PCI Pharma Services. As a Quality Assurance Manager, you will be responsible for overseeing the daily functions of our quality system, ensuring that client specifications are met, and maintaining compliance with regulatory requirements.Key Responsibilities:Work directly...


  • Madison, Wisconsin, United States Piper Companies Full time

    Quality Manager Job DescriptionPiper Companies is seeking a highly skilled Quality Manager to join their team in Madison, WI. As a key member of the organization, the Quality Manager will be responsible for ensuring the highest standards of quality and safety in the laboratory.Key Responsibilities:Develop and maintain quality-related documents, including...


  • Madison, Wisconsin, United States Piper Companies Full time

    Quality Manager Job DescriptionPiper Companies is seeking a highly skilled Quality Manager to join our team in Madison WI.Key Responsibilities:Develop and maintain quality-related documents, including manuals, procedures, and work instructions.Conduct internal quality audits and generate reports to ensure adherence to quality documents.Monitor and evaluate...


  • Madison, Wisconsin, United States Piper Companies Full time

    Job Title: Quality ManagerPiper Companies is seeking a highly skilled Quality Manager to join our team in Madison, WI. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and safety in our food production processes.Responsibilities:Develop and maintain quality-related documents, including manuals,...


  • Madison, Wisconsin, United States TruPath Full time

    Job Summary:We are seeking an experienced Quality Group Leader to join our team at TruPath. The ideal candidate will have recent experience in a similar role, with a strong background in quality assurance and process improvement.Key Responsibilities:Lead and direct the quality team on shift, ensuring that all quality concerns and duties are addressed.Oversee...


  • 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 Octopi Brewing Full time

    Quality Assurance TechnicianAbout the Role:We are seeking a highly detail-oriented and organized Quality Assurance Technician to join our team at Octopi Brewing. As a Quality Assurance Technician, you will play a critical role in ensuring the quality and safety of our products.Key Responsibilities:Perform daily sampling and testing of in-process and finished...


  • Madison, Wisconsin, United States Nelson Miller Group Full time

    {"title": "Quality Assurance and Environmental Health & Safety Manager", "description": "Job SummaryNelson Miller Group is seeking a highly skilled Quality Assurance and Environmental Health & Safety Manager to oversee and implement comprehensive QA/EHS programs across multiple manufacturing sites in the United States.This role requires a strong...


  • Madison, Wisconsin, United States Octopi Brewing Full time

    Quality Assurance TechnicianAbout the Role:We are seeking a highly detail-oriented and organized Quality Assurance Technician to join our team at Octopi Brewing. As a Quality Assurance Technician, you will play a critical role in ensuring the quality and safety of our products.Key Responsibilities:Perform daily sampling and testing of in-process and finished...


  • Madison, Wisconsin, United States Octopi Brewing Full time

    Quality Assurance TechnicianOctopi Brewing is seeking a highly detail-oriented and organized Quality Assurance Technician to join our team. As a Quality Assurance Technician, you will be responsible for ensuring the quality of our products and processes.Key Responsibilities:Perform daily sampling and testing of in-process and finished product to ensure...


  • Madison, Wisconsin, United States Octopi Brewing Full time

    Job Title: Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team at Octopi Brewing. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes, maintaining a clean and organized work environment, and collaborating with our production,...


  • Madison, Wisconsin, United States Thermo Fisher Scientific Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Engineer to join our team at Thermo Fisher Scientific. As a Quality Assurance Engineer, you will be responsible for managing supplier issues and ensuring compliance with regulatory requirements.Key ResponsibilitiesCollaborate with global and local functions to define actions and priorities for...


  • Madison, Wisconsin, United States Plastic Executive Recruiters Full time

    Job Title: Quality EngineerJob Summary: We are seeking a skilled Quality Engineer with expertise in the plastics manufacturing industry to ensure product quality, implement quality assurance measures, and drive continuous improvement.Key Responsibilities:Develop and Implement Quality Standards: Create and implement industry-specific quality standards and...


  • Madison, Wisconsin, United States Octopi Brewing Full time

    Quality Assurance TechnicianOctopi Brewing is seeking a detail-oriented and organized Quality Assurance Technician to join our team. As a key member of our quality control team, you will be responsible for ensuring the highest quality of our products.Key Responsibilities:Perform daily sampling and testing of in-process and finished products to ensure quality...


  • Madison, Wisconsin, United States Octopi Brewing Full time

    Job Title: Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Octopi Brewing. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes, maintaining a clean and organized work environment, and collaborating with our production, liquid...


  • Madison, Wisconsin, United States Octopi Brewing Full time

    Quality Assurance TechnicianAbout the Role:We are seeking a highly detail-oriented and organized Quality Assurance Technician to join our team at Octopi Brewing. As a Quality Assurance Technician, you will play a critical role in ensuring the quality and safety of our products.Key Responsibilities:Perform daily sampling and testing of in-process and finished...


  • 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...