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
- 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 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...RegulatoryShift work
- ...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...RegulatoryShift work
- ...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/...RegulatoryWorldwide
- ...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...RegulatoryRemote work
- ...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
- ...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,...RegulatoryShift work
- ...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
- ...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
- ...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...RegulatoryWork at officeLocal areaEarly shift
- ...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
$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-...RegulatoryFull time- 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...RegulatoryFlexible hours
- ...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
- ...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...RegulatoryWorldwide
$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...RegulatoryFull timeWork at officeLocal areaFlexible hours$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....RegulatoryHourly payFull timeFor contractorsSeasonal workImmediate startFlexible hoursShift work- .... 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,...RegulatoryContract workAfternoon shift
- ...'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,...RegulatoryTemporary workFor contractorsWork at officeLocal areaWorldwide
- ...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...RegulatoryWork at officeImmediate start
- ...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 TechnologiesRegulatoryShift work
$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...RegulatoryWork at officeLocal areaFlexible hours- ...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
- ...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
- 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
- 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...
- ...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...RegulatoryFlexible hours
- ...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...RegulatoryLocal area
- ...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...RegulatoryNight shift
- ...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
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