Quality Assurance Specialist III

2 weeks ago


Allentown, Pennsylvania, United States Integrated Resources, Inc Full time
Job OverviewPosition Title: Quality Assurance Specialist III
Company: Integrated Resources, Inc

Job 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 Trial Division (CTD).

Key Responsibilities:
  • Maintain adherence to current Good Manufacturing Practices (cGMP) with an emphasis on patient safety, facilitating the swift introduction of products.
  • Utilize comprehensive knowledge of industry regulations and processes to meticulously assess the safety, identity, strength, purity, and quality of batch records.
  • Collaborate with clients to fully understand their batch review and release requirements, ensuring all regulatory obligations are met.
  • Conduct thorough analyses of all inputs involved in the batch creation process, considering factors such as environmental monitoring and analytical results.
  • Ensure that any product batches failing to meet in-process and finished product specifications are appropriately quarantined or rejected.
  • Engage with Operations and Quality Assurance teams to resolve any batch release quality concerns.
  • Identify and communicate batch review issues promptly, recommending solutions when necessary.
  • Prioritize batch record evaluations to meet quality objectives efficiently.
  • Deliver exceptional internal and external customer service through clear and timely communication.
  • Represent the Quality Assurance team in internal meetings as required.

Qualifications:
  • A Bachelor’s Degree is required, preferably in a Life Science discipline; an advanced degree is advantageous.
  • 3-5 years of experience in the pharmaceutical or medical device industry within a GMP environment, with a strong preference for those with batch record release experience.
  • Detail-oriented with a keen ability to identify errors or deficiencies in documentation.
  • Strong communication skills, capable of engaging effectively with colleagues at all levels.
  • Familiarity with Quality Systems, including change control and complaint management, is desired, along with knowledge of SAP and Documentum.


  • Allentown, Pennsylvania, United States Maxonic Full time

    Maxonic is dedicated to fostering a strong and enduring partnership with our esteemed client. To meet their requirements, we are seeking a Quality Assurance Specialist III (Medical Device & Manufacturing).Position Overview: Job Title: Quality Assurance Specialist III (Medical Device & Manufacturing)Job Type: Long-term Contract (with potential for extension...


  • Allentown, Pennsylvania, United States Thermo Fisher Scientific Full time

    Work ScheduleFirst Shift (Days)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionWhen you are part of the team at Thermo Fisher Scientific, you'll do...


  • 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...


  • Allentown, Pennsylvania, United States Maxonic Full time

    Maxonic values its long-standing partnerships with clients and is currently seeking a Quality Specialist III (Medical Device & Manufacturing).Position Overview: Job Title: Quality Specialist III (Medical Device & Manufacturing)Job Type: Contractual Role (with potential for extension and full-time conversion)Location: Remote opportunities...


  • Allentown, Pennsylvania, United States Keurig Dr Pepper Full time

    Position Overview:The Quality Assurance Specialist plays a vital role in collaborating with Quality, Operations, and Maintenance teams to execute validation and verification tasks during shifts. This position is essential for upholding the Food Safety Management System as required.Shift & Schedule:This is a full-time role on the Night Shift, following a...


  • Allentown, Pennsylvania, United States AlphaGraphics - US207 Full time

    Job OverviewThe Quality Assurance Specialist plays a crucial role in ensuring that all products meet consumer expectations. This position involves a thorough examination of production processes to guarantee adherence to quality standards and the assessment of final products post-production.Key Responsibilities:Establish acceptable variation ranges for...


  • Allentown, Pennsylvania, United States AlphaGraphics - US207 Full time

    Job OverviewThe Quality Assurance Specialist plays a crucial role in ensuring that products meet consumer expectations. This position involves examining production jobs to verify compliance with quality standards and assessing the final output after manufacturing.Key Responsibilities:Establish acceptable variation ranges for production jobs and identify...


  • 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...


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

    OverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to contribute to the success of a well-established pharmaceutical organization. This role is pivotal in ensuring that quality standards are met and maintained throughout the production process.Key ResponsibilitiesOversee the evaluation,...


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

    OverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to contribute to the success of a prominent pharmaceutical organization. This role is pivotal in ensuring that quality standards are met and maintained throughout the production process.Key ResponsibilitiesOversee the evaluation,...


  • 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 reputable pharmaceutical organization. This role is pivotal in ensuring that quality standards are met and maintained, contributing significantly to the overall success of the company.Key ResponsibilitiesOversee the...


  • 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 that quality standards are met, contributing significantly to the overall success of the organization.Key ResponsibilitiesOversee the...


  • 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...


  • Allentown, Pennsylvania, United States TekWissen ® Full time

    Position: Quality Control InspectorLocation: Allentown, PADuration: 12 MonthsJob Type: ContractWork Type: OnsiteShift Timings: Monday-Friday - 03:15 PM to 11:15 PMPay Rate: $26-$26 per hourCompany Overview: TekWissen Group is a prominent workforce management provider, recognized for its expertise in biotechnology product development services. Our client is a...


  • Allentown, Pennsylvania, United States TekWissen LLC Full time

    Job DescriptionOverview: TekWissen Group is a leading provider of workforce management solutions across the USA and internationally. We are currently seeking a Quality Control Inspector for our client, a prominent player in the biotechnology sector, focused on product development services. This organization is committed to delivering essential laboratory...


  • Allentown, Pennsylvania, United States Patterns india Full time

    Job OverviewWe are seeking a meticulous Quality Control Specialist to manage quality assurance activities, encompassing microbiological testing and chemical evaluations, while ensuring compliance with Good Manufacturing Practices (GMP) and upholding the utmost standards of product excellence and safety.Position Details: This is a full-time role based in a...


  • Allentown, Pennsylvania, United States Advanced Materials & Technology Recruiting Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at Advanced Materials & Technology Recruiting. As a key member of our organization, you will be responsible for ensuring the highest quality standards are met in all aspects of our operations.Key ResponsibilitiesQuality Assurance: Develop and implement quality assurance...


  • Allentown, Pennsylvania, United States Thermo Fisher Scientific Full time

    Work ScheduleEnvironmental ConditionsJob OverviewAt Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale. Join our dedicated team in fulfilling our Mission daily, empowering our clients to enhance global health, cleanliness, and safety. We equip our international teams with the necessary resources to reach...


  • 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...


  • Allentown, Pennsylvania, United States Eastridge Workforce Solutions Full time

    Eastridge Workforce Solutions is collaborating with a prominent entity in the clinical supply chain sector and pharmaceutical packaging, seeking Quality Control Inspectors. These positions are direct-hire opportunities. Key Responsibilities: Ensure compliance with Good Manufacturing Practices (GMP) by conducting quality inspections on equipment, components,...