Quality Assurance Supervisor

4 days ago


Wilmington, Ohio, United States Alkermes Full time
Job Description

Overview:

This position is responsible for providing strategic leadership to the Quality Assurance team, ensuring the safety, identity, strength, purity, and quality of products manufactured at Alkermes. The successful candidate will have a deep understanding of US and European Drug Product GMP requirements and associated guidelines.

Responsibilities:
  • Develop and implement tactical initiatives to ensure compliance with regulatory requirements and company policies.
  • Provide direct oversight for day-to-day quality and compliance of operations, including review and approval of risk assessments, change controls, investigations, corrective/preventive actions, and complaint records.
  • Participate in management processes for quality and compliance, including third-party inspections and completion of applicable commitments.
  • Monitor site metrics pertaining to quality systems and support management review.
  • Support data and documentation review for Annual Product Reviews.
  • Ensure required initial and continuing training of direct reports is carried out and adapted according to need.
  • Support the Internal Audit Program and recall process as required.
Qualifications:
  • Requires a Bachelor's degree in a scientific discipline or equivalent.
  • 6+ years of experience in a Quality Assurance role in the pharmaceutical industry, with experience in parenteral dosage forms or equivalent strongly desired.
  • 3+ years of supervisory/team lead experience preferred.
  • Proficient in Microsoft Office and knowledge of SAP, LIMS, TrackWise preferred.
About Us:

Alkermes is a global biopharmaceutical company committed to developing medicines to address unmet patient needs. We strive to foster a culture of diversity, inclusion, and belonging throughout our business, recognizing that our diversity of thought, background, and perspective makes us stronger.



  • Wilmington, Ohio, United States Alkermes Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Quality Assurance Supervisor to join our team at Alkermes. The successful candidate will be responsible for providing supervision to the Quality Assurance On-the-Floor (OTF) team, supporting sterile and oral solid dose manufacturing operations. This role will provide direct oversight for...


  • Wilmington, Ohio, United States Ferno-Washington, Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Inspector to join our team at Ferno-Washington, Inc. As a Quality Assurance Inspector, you will be responsible for inspecting final products and components at various stages of the production process.Key ResponsibilitiesInspect raw materials, parts, components, and finished products for compliance...


  • Wilmington, Ohio, United States Air Transport International Full time

    Job SummaryWe are seeking a highly skilled and experienced Aviation Quality Assurance Manager to join our team at Air Transport International. The successful candidate will be responsible for managing the company's C.A.S.E. membership and internal/external audit program, as well as vendor approval and oversight.Key ResponsibilitiesManage the Continuous...


  • Wilmington, Ohio, United States Astrix Full time

    Job Title: Quality Assurance Laboratory TechnicianAstrix is seeking a highly skilled Quality Assurance Laboratory Technician to join our team. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.Key Responsibilities:Conduct visual inspections of equipment and...


  • Wilmington, Ohio, United States Ferno Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Inspector to join our team at Ferno. As a key member of our quality control team, you will be responsible for ensuring that our final products meet the highest standards of quality and safety.Key ResponsibilitiesConduct thorough inspections of raw materials, components, and finished products to...


  • Wilmington, Ohio, United States Astrix Technology Full time

    Job Title: Vial InspectorJob Summary:Astrix Technology is seeking a skilled Vial Inspector to join our team. As a Vial Inspector, you will be responsible for inspecting finished vials and syringes for defects, performing daily process activities in compliance with standard operating procedures (SOPs), and operating equipment in compliance with SOPs.Key...


  • Wilmington, Ohio, United States Alkermes Full time

    Job DescriptionThe Quality Assurance Senior Associate - Laboratory Support is responsible for supporting daily operations and monitoring compliance of the laboratories.Key ResponsibilitiesAct as QA Lab Support representative on special committees and teams.Lead specific aspects of a project and guide solutions for difficult problems identifying best...


  • Wilmington, Ohio, United States Ferno Full time

    Job SummaryAs a Quality Assurance Inspector II at Ferno, you will play a critical role in ensuring the quality of our final products and components. Your attention to detail and ability to follow documentation requirements will be essential in preparing inspection records and writing Non Conformance reports.Key ResponsibilitiesInspect raw materials, parts,...


  • Wilmington, Ohio, United States Astrix Technology Full time

    Job Summary:We are seeking a skilled Vial Inspection Technician to join our team at Astrix Technology. As a key member of our manufacturing team, you will be responsible for inspecting finished vials and syringes for defects, ensuring the highest quality standards are met.Key Responsibilities:* Perform daily process activities in compliance with standard...

  • Kitchen Supervisor

    4 weeks ago


    Wilmington, Ohio, United States Ralph's American Grill Full time

    Job Title: Kitchen SupervisorRalph's American Grill is seeking a highly skilled and experienced Kitchen Supervisor to join our team. As a key member of our kitchen staff, you will be responsible for ensuring the smooth operation of our kitchen, maintaining high standards of food quality and safety, and leading a team of cooks and kitchen staff.Key...

  • Office Supervisor

    3 weeks ago


    Wilmington, Ohio, United States AVI Foodsystems Full time

    Office Supervisor OpportunityAVI Foodsystems is seeking a highly motivated and organized individual to fill the role of Office Supervisor at Wilmington College in Wilmington, OH.As a leading food service company, AVI Foodsystems prides itself on providing exceptional service and quality food to its clients. The successful candidate will be responsible for...


  • Wilmington, Ohio, United States AZEK Company Inc. Full time

    Job SummaryWe are seeking a highly skilled and experienced Blending Supervisor to join our team at AZEK Company Inc. As a Blending Supervisor, you will be responsible for overseeing and assisting Shift Leaders, Operators, and Rail Car Attendants to ensure organizational commitments regarding people, safety, quality, delivery, and cost expectations are...


  • Wilmington, Ohio, United States The AZEK Company Full time

    Job Title: Night Shift Blending SupervisorAt The AZEK Company, we are seeking a highly skilled and experienced Night Shift Blending Supervisor to join our team. As a key member of our blending operations, you will be responsible for overseeing and assisting shift leaders, operators, and rail car attendants to ensure that our organizational commitments...


  • Wilmington, Ohio, United States Alkermes Full time

    Job SummaryThis position provides direct leadership across shifts in manufacturing clinical and commercial products. The successful candidate will manage multi-disciplined teams of exempt and non-exempt members in a pharmaceutical production area to ensure that all manufacturing systems, production processes, equipment, and the final pharmaceutical product...


  • Wilmington, Ohio, United States Inter-Con Security Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Account Manager to join our team at Inter-Con Security Systems, Inc. The successful candidate will be responsible for managing daily Security Officer operational staffing requirements and administrative functions, meeting business goals and objectives in Cincinnati.Key ResponsibilitiesConduct...


  • Wilmington, Ohio, United States Benelux Tek Group, Inc Full time

    Aircraft Maintenance Controller Job DescriptionBenelux Tek Group Inc. (Aerospace Division) is seeking a highly skilled certified Aircraft Maintenance Controller for one of its clients in Wilmington, Ohio, USA.Job OverviewThe Maintenance Controller reports to the Supervisor of Maintenance Control and is responsible for coordinating the correction of...


  • Wilmington, Ohio, United States Assured Nursing Full time

    Assured Nursing is seeking a skilled Radiology Technologist to fill a contract position in Wilmington, Ohio.Job DetailsSpecialty: Radiology TechnologistDiscipline: Allied Health ProfessionalDuration: 15 weeks40 hours per weekShift: 8 hours, eveningsEmployment Type: TravelAs a Radiology Technologist with Assured Nursing, you will have the opportunity to work...


  • Wilmington, Ohio, United States Assured Nursing Full time

    Job Opportunity for CT TechnologistAssured Nursing is seeking a skilled CT Technologist for a travel position in a dynamic healthcare setting.Key ResponsibilitiesConduct high-quality computed tomography scansCollaborate with radiologists and other healthcare professionalsEnsure accurate and efficient imaging proceduresProvide exceptional patient care and...


  • Wilmington, Ohio, United States ManpowerGroup Full time

    Job Title: Gatekeeper - 1st ShiftWe are seeking a highly skilled and detail-oriented Gatekeeper to join our team in Wilmington, OH. As a Gatekeeper, you will play a critical role in ensuring the smooth operation of our production/assembly area.Key Responsibilities:Work on assembly lines, production, and packaging in various capacities according to...


  • Wilmington, Ohio, United States Azek Company Full time

    Job SummaryAs a Night Shift Blending Supervisor at Azek Company, you will oversee and assist Shift Leaders, Operators, and Rail Car Attendants to ensure organizational commitments regarding people, safety, quality, delivery, and cost expectations are met.Key ResponsibilitiesCollaborate with other departments to determine, analyze, and mitigate Night Shift...