Quality Assurance Supervisor

3 weeks ago

Allentown, United States Germer International - Pharmaceutical Recruiting Full time

Quality Assurance Operations Supervisor


Are you interested in working for a global, growing leader in anesthetic products? Our client is looking for a seasoned QA professional, that can manage a team of direct reports, as well as overseeing Quality Assurance Operations on the manufacturing floor.


Essential Duties and Responsibilities

  • Overall responsibility for coordinating the disposition of API and drug product
  • Coordinates batch documentation review with Operations groups to ensure GMP compliance and timely delivery of products to customers
  • Ensures all documentation and API/drug product batches produced meet the requirements of GMPs and other regulatory health authority requirements
  • Supervises day-to-day functions of the QA Operations team
  • Mentors/coaches and provides succession planning for direct reports
  • Ensures batches meet GMP requirements and all production and QC documentation has been reviewed prior to disposition
  • If any errors or data integrity issues occur during the manufacturing, packaging, labelling, and testing of API/drug product, that they have been investigated according to internal procedures.
  • Ensures QC data meets specifications and any OOSs are investigated per internal procedures
  • Provides QA presence on API/drug product filling/packaging line through documented walkthroughs to ensure GMP compliance
  • Works with global partners in EU/UK QA to ensure batches are dispositioned and records provided in a timely manner
  • Manages drug product complaint program ensuring samples are received in a timely fashion and investigations meet established internal procedural requirements and reports back to customer service team through approved software programs
  • Prepares metrics for weekly, monthly and quarterly Management meetings

Key Competencies (knowledge, skills, and abilities every person must possess to be successful), i.e.

  • Critical Thinking skills using “Risk Based” logic and reasoning to identify the strengths and weaknesses in QMS, recommend and institute solutions, conclusions, and approaches to problems
  • Demonstrated ability to evaluate quality matters by leveraging GMP experience, analyzing data, while using FDA Risk Based type approaches
  • Attention to detail/ sense of urgency- ability to act quickly and escalate issues
  • Excellent customer service skills and professional demeanor always to interface effectively with all internal and external customers
  • Excellent verbal and written communication skills
  • Energetic, enthusiastic, and motivational disposition


Education/Experience

  • Bachelor’s degree required with Bachelor of Science preferred
  • 5+ years’ experience in Pharmaceutical/Biotech industry
  • Experience in TrackWise, EDMS, LMS or other such software tools for managing the QMS
  • Working knowledge of 21 CFR part 210/211, and part 11, FDA guidance. Knowledge of 21 CFR part 820 Medical Device Regulations preferred.

  • Supervisor, Quality Assurance

    2 months ago

    Allentown, United States Premium Waters Full time

    Job DescriptionJob DescriptionJob Title: QA Supervisor Reports to: Quality Assurance Manager FLSA Status: Exempt Shift: Days Department: Quality Assurance Prepared by: Human Resources Approved By: Plant Manager Date: July 22, 2022Qualifications: 4 year degree in Quality or related degree is preferred; plus 2 years previous manufacturing and Supervision...

  • Transportation Quality Assurance Inspector Supervisor

    3 weeks ago

    Allentown, United States Johnson, Mirmiran & Thompson Full time

    Transportation Quality Assurance Inspector Supervisor LinkedIn Twitter Email Message Share Construction Management/Inspection - Transportatio Allentown, PA * ID: ...

  • Transportation Quality Assurance Inspector Supervisor

    3 weeks ago

    Allentown, Pennsylvania, United States Johnson, Mirmiran & Thompson Full time

    Transportation Quality Assurance Inspector SupervisorLinkedIn Twitter Email Message ShareConstruction Management/Inspection - Transportatio Allentown, PA * ID: 21767* Full-Time/RegularJohnson, Mirmiran & Thompson is a dynamic, 100% employee-owned consulting firm of more than 2,300 professionals that provides a full range of multi-disciplined...

  • Quality Assurance Technician

    1 month ago

    Allentown, United States Premium Waters Inc Full time

    Job Title: QA Technician Reports to: Quality Assurance SupervisorFLSA Status: Non-Exempt Shift: Days/NightsDepartment: Quality Assurance Prepared by: Human Resources Approved By: Plant Manager Date: July 29, 2024Qualifications: High School diploma or equivalent, undergraduate degree preferred Food, beverage, or liquid consumer product...

  • Quality Assurance Technician

    1 month ago

    Allentown, United States Premium Waters Full time

    Job DescriptionJob DescriptionJob Title: QA Technician Reports to: Quality Assurance SupervisorFLSA Status: Non-Exempt Shift: Days/NightsDepartment: Quality Assurance Prepared by: Human Resources Approved By: Plant Manager Date: July 29, 2024Qualifications: High School diploma or equivalent, undergraduate degree preferred Food, beverage, or liquid consumer...

  • Quality Assurance Specialist

    2 days ago

    Allentown, Pennsylvania, United States Tekwissen Full time

    Job Description**Job Summary:**We are seeking a highly skilled Quality Assurance Specialist to join our team at TekWissen Group. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of clinical products processed through primary and secondary packaging, warehouse, and distribution operations.Key Responsibilities:Apply Good...

  • Quality Assurance Inspector

    4 weeks ago

    Allentown, United States VeeRteq Solutions Inc. Full time

    Job DescriptionJob DescriptionTitle: Quality Assurance Inspector Location: Allentown, PA, 18106 Duration: 12 Months Job Type: Contract Work Type: Onsite Shift : Monday-Friday - 06.45 AM to 02.45 PMJob Description Our company seeks a Quality Assurance Inspector responsible for the quality of clinical products processed through primary and secondary...

  • Quality Assurance Inspector

    3 days ago

    Allentown, United States Careers Integrated Resources Inc Full time

    Job Title: Quality Assurance Inspector Job Location: Allentown, PA Job Duration: 12 months (possibility of extension) Shift: Mon. to Fri. 6:45 am - 2:45 pm Payrate: $25.90/Hour Job Responsibilities Responsible for the quality of clinical products processed through primary and secondary packaging, warehouse, and distribution...

  • Quality Assurance Inspector

    4 weeks ago

    Allentown, United States TekWissen LLC Full time

    Job DescriptionJob DescriptionOverview TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential...

  • Quality Assurance Inspector

    1 week ago

    Allentown, United States Integrated Resources Full time

    Job Description: Hours: First Shift 6:45am-2:45pm, Monday-Friday. OT as needed What will you do? Our company seeks a Quality Assurance Inspector responsible for the quality of clinical products processed through primary and secondary packaging, warehouse, and distribution operations. This role requires attention to details, the keen ability to Client defects...

  • Quality Assurance Inspector

    1 week ago

    Allentown, Pennsylvania, United States Eastridge Full time

    Job OverviewEastridge Workforce Solutions is collaborating with a prominent entity in the clinical supply chain sector and pharmaceutical packaging to identify Quality Assurance Inspectors. These positions are direct-hire opportunities.Key Responsibilities:Ensure compliance with Good Manufacturing Practices (GMP) by conducting quality inspections on various...

  • Quality Assurance Inspector

    4 weeks ago

    Allentown, United States TekWissen ® Full time

    Position: Quality Assurance InspectorLocation: Allentown, PA, 18106Duration: 12 MonthsJob Type: ContractWork Type: OnsiteShift: Monday-Friday - 06.45 AM to 02.45 PMPay Rate: $26-$26/hrOverview TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients...

  • Quality Assurance Inspector

    1 week ago

    Allentown, United States Tekwissen Full time

    Overview TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific...

  • Quality Assurance Specialist III

    1 week ago

    Allentown, Pennsylvania, United States Integrated Resources, Inc Full time

    Job OverviewPosition Title: Quality Assurance Specialist IIICompany: Integrated Resources, IncJob Summary:This role is integral to the Quality Assurance team, focusing on the evaluation and approval of clinical and commercial documentation. The Quality Assurance Specialist III will ensure compliance with regulatory standards while supporting the Clinical...

  • Lead Quality Assurance Expert

    5 days ago

    Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full time

    OverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to enhance the quality assurance processes within a prominent pharmaceutical organization. This role is pivotal in ensuring that quality standards are met and maintained throughout the production cycle.Key ResponsibilitiesOversee the...

  • Quality Assurance Inspector

    3 weeks ago

    Allentown, United States Thermo Fisher Scientific Full time

    Work Schedule7 1/2 hr shiftEnvironmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves,...

  • Quality Assurance Inspector

    4 weeks ago

    Allentown, United States Thermo Fisher Scientific Full time

    Work Schedule 7 1/2 hr shift Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning,...

  • Transportation Quality Assurance Inspector

    1 month ago

    Allentown, United States Johnson, Mirmiran & Thompson Full time

    Transportation Quality Assurance Inspector LinkedIn Twitter Email Message Share Construction Management/Inspection - Transportatio Allentown, PA * ID: 21225 * Full-Time/Regular Johnson, Mirmiran & Thompson is a dynamic, 100% employee-owned consulting firm of more than 2,300 professionals that provides a full range of multi-disciplined engineering,...

  • Transportation Quality Assurance Inspector

    2 weeks ago

    Allentown, United States Johnson, Mirmiran & Thompson Full time

    Transportation Quality Assurance Inspector LinkedIn Twitter Email Message Share Construction Management/Inspection - Transportatio Allentown, PA * ID: 21766 * Full-Time/Regular Johnson, Mirmiran & Thompson is a dynamic, 100% employee-owned consulting firm of more than 2,300 professionals that provides a full range of multi-disciplined engineering,...

  • Lead Quality Assurance Analyst

    5 days ago

    Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full time

    OverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to enhance our client's established pharmaceutical operations. This role is pivotal in ensuring the quality and compliance of products, contributing significantly to the overall success of the organization.Key ResponsibilitiesOversee the...