Quality Assurance Specialist

4 weeks ago


Billerica, Massachusetts, United States Randstad Life Sciences US Full time

Quality Assurance Specialist needed for aseptic fill/finish manufacturing suite. The ideal candidate will provide Quality oversight activities and technical expertise to ensure compliance with company guidelines and CGMP regulations.

Key Responsibilities:

  • Conduct investigations and make recommendations for targeted data and information collection.
  • Collaborate with production support teams to identify root cause and determine corrective action/preventative actions.
  • Resolve unique and/or adverse situations and make quality recommendations based on evidence.
  • Review and approve protocols, validation documents, investigations, and procedures.
  • Approve change controls and represent Quality in Change Control Board meetings.
  • Provide Quality on the floor presence in support of manufacturing operations.
  • Represent QA in internal team meetings, processes, and initiatives.
  • Alert management of critical issues and provide achievable solutions.
  • Actively promote safety rules and awareness.

Requirements:

  • BS/BA degree in a scientific discipline with 2 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment.
  • Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities.
  • Ability to travel up to 10% domestically.


  • Billerica, Massachusetts, United States LanceSoft Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at LanceSoft. The ideal candidate will have a strong background in quality control and assurance, with experience in process validation and computer software validation.The successful candidate will be responsible for developing, modifying, and maintaining quality...


  • Billerica, Massachusetts, United States Access Vascular Inc Full time

    Job Title: Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Access Vascular Inc. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and processes.Key Responsibilities:- Collaborate with manufacturing and supply chain teams to ensure...


  • Billerica, Massachusetts, United States LanceSoft Full time

    Job SummaryAt LanceSoft, we are seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance and process validation, with a proven track record of ensuring the highest standards of quality in a manufacturing environment.Key Responsibilities- Develop and implement quality...


  • Billerica, Massachusetts, United States TAJ Technologies Inc Full time

    Job Summary:We are seeking a Quality Assurance Specialist to join our team at TAJ Technologies Inc. The ideal candidate will have a strong background in quality assurance and a passion for ensuring the highest standards of product quality.Key Responsibilities:Develop and maintain quality standards and protocols for processing materials into partially...


  • Billerica, Massachusetts, United States Randstad Full time

    Job Title: Gmp Quality Assurance SpecialistJob Summary: We are seeking a skilled Gmp Quality Assurance Specialist to join our team. As a Gmp Quality Assurance Specialist, you will be responsible for ensuring the accurate labeling and packaging of life-changing pharmaceuticals.Responsibilities:* Conduct visual inspections to ensure products meet the highest...


  • Billerica, Massachusetts, United States Lantheus Full time

    Job DescriptionLantheus is a leading company in the medical imaging field, with a strong presence in Bedford, Massachusetts, and offices in New Jersey, Canada, and Sweden.We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for providing quality oversight activities for the...


  • Billerica, Massachusetts, United States Quanterix Full time

    At Quanterix, we are seeking a highly motivated Quality Assurance Specialist to join our Accelerator Laboratory in Billerica, MA.The successful candidate will be responsible for quality review of documents for IVD products and compliance with the QMS.This role will support vendor qualification, audits, complaints, and investigations within the Quanterix...


  • Billerica, Massachusetts, United States MassHire Lowell Career Center Full time

    Job Summary:MassHire Lowell Career Center is seeking a Quality Assurance Specialist to join our team. The ideal candidate will have experience in a formalized FDA or ISO Quality Management System and be able to work independently to perform and process first piece inspections and final inspections with proper documentation.Responsibilities: · Assist in...


  • Billerica, Massachusetts, United States Pace Industries Full time

    Job SummaryPace Industries is seeking a Quality Assurance Specialist to perform inspections and tests on in-process and finished product to ensure quality standards and process controls are being met. The ideal candidate will have numeracy skills to calibrate and measure, be a self-starter, and be dedicated to Department/Company Objectives.Key...


  • Billerica, Massachusetts, United States Gabriele & Company Full time

    Gabriele & Company, a leading recruiting firm specializing in manufacturing and supply chain professionals, is working with a dynamic local manufacturer known for producing highly engineered, critical components utilized in Cloud, Industrial, eMobility, and medical device products. Recent growth requires the addition of a Quality Assurance Specialist, for...


  • Billerica, Massachusetts, United States Quanterix Full time

    Quality Assurance Specialist II Job DescriptionAbout the Role:We are seeking an experienced Quality Assurance Specialist II to join our team at Quanterix. The successful candidate will be responsible for ensuring the quality and compliance of our products and services.Key Responsibilities:* Establish and maintain a culture of trust and compliance with...


  • Billerica, Massachusetts, United States Lantheus Full time

    Lantheus is a leading company in the field of medical imaging, with a strong presence in Bedford, Massachusetts, and offices in New Jersey, Canada, and Sweden. With over 60 years of experience, Lantheus has pioneered the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.The company is an entrepreneurial,...


  • Billerica, Massachusetts, United States TAJ Technologies Inc Full time

    Job Title: Sr Quality EngineerAt TAJ Technologies Inc, we are seeking a highly skilled Sr Quality Engineer to join our team. As a key member of our quality assurance team, you will be responsible for developing, implementing, and maintaining quality standards and protocols for processing materials into partially finished or finished materials products.Key...


  • Billerica, Massachusetts, United States Actalent Full time

    Job Title: Sr. Quality Assurance ConsultantJob DescriptionAs a Senior Quality Assurance Consultant, you will serve as a Subject Matter Expert on applicable standards and regulations for the organization. Your key responsibilities will include driving inspection readiness and improvement to regulatory inspection processes relating to cGMP, including FDA,...


  • Billerica, Massachusetts, United States Prostaff Solutions LLC Full time

    Job SummaryProStaff Workforce Solutions is seeking a Senior Associate, Quality Assurance for one of the largest pharmaceutical companies in Billerica, MA.Our client is a leading pharmaceutical company specializing in radiopharmaceuticals and formulation, analytical methods development, and production of parenteral drugs.As a Senior Associate, Quality...


  • Billerica, Massachusetts, United States Access Vascular Inc Full time

    Job Title: Senior Manager, Quality AssuranceAbout the Role:We are seeking a highly skilled and experienced Senior Manager, Quality Assurance to support our Manufacturing Quality team. This role is critical in ensuring that our products meet the highest standards of quality and compliance.Key Responsibilities:Lead and manage the Manufacturing Quality team to...


  • Billerica, Massachusetts, United States Access Vascular Inc Full time

    Quality Control Inspection TechnicianThe QC Technician provides direct quality support to manufacturing and supply chain operations. Responsibilities include inspecting materials received, production records, subassemblies, and finished products. Closely collaborate with manufacturing and supply chain teams to ensure that production outputs meet or exceed...


  • Billerica, Massachusetts, United States Access Vascular Inc Full time

    Job SummaryThe Quality Control Technician provides direct quality support to manufacturing and supply chain operations, ensuring production outputs meet or exceed requirements and demands.Key ResponsibilitiesSupport manufacturing and supply chain functions to ensure quality, quantity, and timeliness of production outputs.Identify and implement effective...


  • Billerica, Massachusetts, United States Access Vascular Inc Full time

    Job OverviewThe Quality Control Technician plays a vital role in ensuring the quality and integrity of our products. This position requires a high level of attention to detail and organizational skills, with a strong understanding of manufacturing documentation and Good Documentation Practices (GDP).Key ResponsibilitiesCollaborate with manufacturing and...


  • Billerica, Massachusetts, United States MassHire Lowell Career Center Full time

    Quality Inspector Role at MassHire Lowell Career CenterThe Quality Inspector will be responsible for performing incoming inspections on electro mechanical parts, using drawings specifications to follow inspection procedures. This role will also involve generating non-conforming reports on products.The schedule for this position is Monday through Friday, 6am...