Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

GMP Quality Assurance Specialist - Biotech & Regulatory Support

Isotopia USA

Isotopia USA in New York seeks a Quality Assurance Specialist to ensure safe and efficient production. Ideal candidates will have a Bachelor’s degree and 5+ years in quality control/assurance, preferably in GMP manufacturing. You will create and manage quality systems, support audits, and assist in regulatory preparations. The role requires strong problem-solving, communication skills, and the ability to maintain accuracy in a fast-paced environment. We offer competitive salaries, benefits, and advancement opportunities. #J-18808-Ljbffr Isotopia USA

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the GMP Quality Assurance Specialist - Biotech & Regulatory Support in Westfield, NJ vacancy
  • Isotopia USA, a global biotech company, seeks a Quality Assurance Administrative Specialist at our Westfield, NY site. You will...  ...ensure cGMP compliance, and support regulatory filings, with a focus on accurate...  ...correspondence to FDA and EU GMP requirements. Strong... 
    Regulatory

    Isotopia USA

    Westfield, NJ
    2 days ago
  •  ...Isotopia is a global biotech company manufacturing...  ...and detail-oriented Quality Assurance Specialist to join our dynamic team...  ..., implementation and support of a comprehensive...  ...programs, including GMP and GDP training. Support...  ...and submission of regulatory filings, agency responses... 
    Regulatory
    Shift work

    Isotopia USA

    Westfield, NJ
    1 day ago
  •  ...Job Title: Quality Assurance Administrative Specialist Isotopia is a global biotech company manufacturing key ingredients...  ...), and applicable EU GMP requirements. You...  ...manufacturing site. Support the creation,...  ...preparation and submission of regulatory filings, agency... 
    Regulatory
    Shift work

    Isotopia USA

    Westfield, NJ
    1 day ago
  •  ...seeking an experienced Quality Assurance Specialist to join our team....  .... This role supports GxP operations, oversees...  ...with FDA, EU-GMP, GDP, ICH-GCP, DSCSA...  ...and processes meet regulatory and customer expectations...  ...Supply, Pharmaceutical, Biotech, CRO, CDMO, or GMP/... 
    Regulatory
    Worldwide

    JUPITER RESEARCH SERVICES INC

    Edison, NJ
    10 days ago
  •  ...provider in Rahway, New Jersey, seeks an IT Support Specialist to build and support laboratory computing systems in a GMP environment. The role requires hands-on experience...  ...and knowledge of GxP operations according to regulatory standards. Ideal candidates will ensure... 
    Regulatory
    Remote work

    TechDigital Group

    Rahway, NJ
    2 days ago
  •  ...Quality Assurance Specialist The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Vector External...  ...compliance with regulatory and industry expectations...  ...support and guidance during GMP events and initiation of... 
    Regulatory

    Omni Inclusive

    Summit, NJ
    4 days ago
  •  ...Summit, NJ. You will manufacture blood‑derived components in a controlled, cGMP cleanroom under supervision, following SOPs and regulatory requirements. Training runs 1-6 weeks with 9:00 AM-5:00 PM Mon-Fri initially, then a Quad shift. A biology/chemistry background,... 
    Regulatory
    Shift work

    Spectraforce Technologies

    Summit, NJ
    17 hours ago
  •  ...Merck & Co., Inc. in Rahway, NJ seeks a GMP Analytical Director to lead a scientific team supporting method validation, clinical release and stability testing...  ...drive strategic initiatives. The role emphasizes regulatory knowledge, cross-functional leadership, and talent... 
    Regulatory

    Jobleads-US

    Rahway, NJ
    3 days ago
  •  ...Specialist, QA OperationsSpecialist, QA Operations...  ...responsible for quality oversight of Cell...  ...Manager of Quality Assurance Operations....  ...clinical manufacturing GMP/batch related documentation...  ...cGMPs and global regulatory guidelines and requirements. Supports Risk Assessments/... 
    Regulatory

    Omni Inclusive

    Warren, NJ
    2 days ago
  •  ...Quality Assurance Specialist, Designated Complaint Unit (Americas) - Hybrid 5 days...  ...per applicable internal and regulatory requirements. Perform initial...  ...handling. Provide support for stakeholders and ensure...  ...regulations (FDA, ISO 13485, CFR, GMP, etc.) preferred Proficient... 
    Regulatory
    Work at office
    Local area
    Early shift

    WSA – Wonderful Sound for All

    Port Reading, NJ
    3 days ago
  •  ...MSD Malaysia is seeking a GMP Analytical Director in Rahway, NJ to lead a team supporting GMP analytical activities for a small molecule portfolio. You will oversee...  ...with collaboration across senior management and regulatory requirements (cGMP, ICH, FDA). #J-18808-Ljbffr... 
    Regulatory

    Jobleads-US

    Rahway, NJ
    2 days ago
  • $70k - $75k

    A leading food manufacturer is seeking a Regulatory Compliance Specialist to coordinate product labeling projects and maintain compliance documentation...  ...degree and at least 3 years of experience in quality assurance within a food manufacturing environment. This full-... 
    Regulatory
    Full time

    Emmi Desserts

    Kenilworth, NJ
    1 day ago
  • Merck is seeking a Senior Specialist, 880 Safety & Quality Compliance Operations, to lead safety culture, GMP compliance, and quality governance...  ...Non‑Sterile Operations in support of the clinical...  ...time execution and sustained regulatory compliance. #J-18808-Ljbffr... 
    Regulatory
    Flexible hours

    Merck

    Rahway, NJ
    3 days ago
  •  ...auditing experience. Job Title: Quality Specialist- II -Hybrid Job Location:...  .... Serve as the Quality Assurance Unit (QAU) in compliance...  ...in LIMS systems Audit CROs supporting GCP/GLP studies Support FDA...  ...Review and develop SOPs; ensure regulatory compliance Provide GLP/GCP... 
    Regulatory

    AllSTEM Connections

    Rahway, NJ
    1 day ago
  •  ...seeking an Associate Director of Internal Auditing to lead internal audits of GMP facilities and systems, ensuring compliance with worldwide regulations. The role covers quality systems, regulatory intelligence, and risk management, with hybrid work and 25% travel between... 
    Regulatory
    Worldwide

    MSD Malaysia

    Rahway, NJ
    2 days ago
  • $70k - $75k

     ...clinical, manufacturing, regulatory, and IP capabilities. We believe...  ...important medicines. The Quality Assurance Specialist is a regular employee in a...  ...will be responsible for supporting Kashiv BioSciences Quality...  .... Ensure adherence to GMP good documentation practices... 
    Regulatory
    Full time
    Work at office
    Local area
    Flexible hours

    Kashiv Biosciences LLC

    Piscataway, NJ
    17 hours ago
  • $19 per hour

    Quality Assurance Associate (Food Manufacturing) Cranford, NJ Hi, we're Nuts...  ..., and procedures. This role supports the facility in meeting...  ...assurance, food safety, and regulatory requirements by partnering with...  ...associate, visitor, and contractor GMP and Food Defense compliance.... 
    Regulatory
    Hourly pay
    Full time
    For contractors
    Seasonal work
    Immediate start
    Flexible hours
    Shift work

    Nuts.com

    Cranford, NJ
    4 days ago
  •  .... Job Title :QA Label Specialist Location : Summit, NJ...  ...Contract Overview The Quality Assurance Label Control (QALC) Labeling Specialist supports the cGMP Label Control...  ...of current GMPs and regulatory guidelines. Requirements...  ...-Data Integrity/GMP/CSV Manhattan, NY $58,... 
    Regulatory
    Contract work
    Afternoon shift

    Joulé

    Summit, NJ
    2 days ago
  •  ...'s top pharmaceutical, biotech, academic and healthcare...  ...maintenance projects, regulatory and safety compliance,...  ...safety, environmental, quality, OSHA, building code, and...  ...requirements; GMP/GLP environment experience...  ...infrastructure strategies that support business continuity,... 
    Regulatory
    Temporary work
    For contractors
    Work at office
    Local area
    Worldwide

    GENEWIZ from Azenta Life Sciences

    South Plainfield, NJ
    3 days ago
  •  ...global benchmark for sustainability, quality and integrity. Our 99,600 employees...  ...interconnected world.Job Description The Quality Assurance Specialist II, Cosmetics and Hygiene, assists...  ...according to ISO 19011 standards, support in regulatory audits, and remains knowledgeable of... 
    Regulatory
    Work at office
    Immediate start

    SGS

    Union, NJ
    2 days ago
  •  ...Manufacturing Management. Qualifications include a degree or relevant experience in biology/chemistry, GMP knowledge, and strong documentation skills. Candidates must be prepared for routine cleanroom work and regulatory requirements. #J-18808-Ljbffr Spectraforce Technologies
    Regulatory
    Shift work

    Spectraforce Technologies

    Summit, NJ
    17 hours ago
  • $70k - $75k

     ...&D, clinical, manufacturing, regulatory, and IP capabilities. We believe...  ...Summary The Manufacturing Quality Assurance (MQA) Specialist I, II, and III is responsible for supporting and ensuring compliance with...  ...and retest date for all the GMP raw materials through vendor... 
    Regulatory
    Work at office
    Local area
    Flexible hours

    Kashiv Biosciences LLC

    Piscataway, NJ
    3 days ago
  •  ...biotechnology firm in New Jersey is seeking a Training & Development Specialist to implement training programs for manufacturing processes....  ..., developing course content, and ensuring compliance with regulatory standards. This role offers an opportunity to work in a dynamic... 
    Regulatory

    TechDigital Group

    Summit, NJ
    1 day ago
  •  ...Summit, NJ site. You will lead site-wide EHS programs with a focus on risk assessments, ergonomics, investigations, and regulatory compliance in a GMP manufacturing environment. The ideal candidate brings 5+ years of EHS experience, strong project management skills, and... 
    Regulatory

    Bristol Myers Squibb

    Summit, NJ
    2 days ago
  • A prominent staffing firm is seeking a Regulatory Site Quality Specialist in Florham Park, NJ. The role involves managing the OTC drug listing portfolio...  ...or engineering and at least 5 years of experience in a GMP environment. Candidates should possess a strong... 
    Regulatory

    Insight Global

    Florham Park, NJ
    1 day ago
  • Garonit Pharmaceutical is looking for a detail-oriented QA Associate in Flanders, NJ and Fairfield, NJ. This role supports daily Quality Assurance operations, ensuring product quality and cGMP compliance. Responsibilities include issuing and reviewing batch records, preparing... 

    Garonit Pharmaceutical

    Fairfield, Essex County, NJ
    3 days ago
  •  ...Global QA Patients Operations Specialist The primary responsibility...  ...Operations Specialist is to support the Onboarding and Maintenance...  ...language required). • Quality Operations and Systems Support...  ...Patient Operations and Apheresis Regulatory Vigilance, CTDO. Specific... 
    Regulatory
    Flexible hours

    Omni Inclusive

    Summit, NJ
    1 day ago
  •  ...Remediation Lead, the AAA Remediation QA Specialist is responsible for GMP quality assurance oversight of remediation...  ...or validation related matters in support of record backlog reduction.Responsible...  ...Inspection Readiness program for regulatory inspections, Client baseline... 
    Regulatory
    Local area

    Saviance

    Millburn, NJ
    2 days ago
  •  ...Cell Therapy Development and Operations, ensuring GMP-compliant processes and timely label issuance...  ..., and coordinates with global/regional regulatory requirements, quality metrics, and project initiatives to support new launches and investigations. #J-18808-Ljbffr... 
    Regulatory
    Night shift

    Bristol-Myers Squibb

    Summit, NJ
    4 days ago
  •  ...player is seeking a Compliance Specialist to ensure equipment compliance and support operational excellence in a dynamic...  ...external partners to uphold regulatory standards and drive compliance...  ...setting and have a passion for quality assurance, this is an exciting opportunity... 
    Regulatory

    TechDigital Group

    Summit, NJ
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to GMP Quality Assurance Specialist - Biotech & Regulatory Support. Be the first to apply!