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 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
- ...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, 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
$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- ...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 experienced Quality Assurance Specialist to join our team. In... ...returns. This role supports GxP operations,... ...compliance with FDA, EU-GMP, GDP, ICH-GCP, DSCSA... ...and processes meet regulatory and customer... ...Supply, Pharmaceutical, Biotech, CRO, CDMO, or GMP/GDP...RegulatoryWorldwide
- .... 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
$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- ...of the Global QA Patients Operations Specialist is to support the Onboarding and Maintenance of Apheresis... ...writing (English language required). Quality Operations and Systems Support... ...Quality Patient Operations and Apheresis Regulatory Vigilance, CTDO. Specific Knowledge,...RegulatoryFlexible 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
$65k
...Job Description The Quality Assurance Specialist II, Cosmetics and Hygiene, assists with the standardization and harmonization, and continuous... ...internal processes according to ISO 19011 standards, supports regulatory audits, and remains knowledgeable of regulatory...RegulatoryImmediate start- ...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
- ...S12 Cell Therapy manufacturing facility. In this pivotal role, you will lead the Label Operations team, ensuring compliance with regulatory standards and efficient label issuance processes. The ideal candidate should have a B.S. Degree with at least 5 years of relevant...Regulatory
- ...cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the... ...• Support internal and external audits and regulatory inspections if required. Assist with document...Regulatory
- JUPITER RESEARCH SERVICES INC is seeking a Quality Assurance Specialist to oversee the quality and compliance of our clinical trial materials. You will ensure that products meet regulatory standards throughout their lifecycle, from storage to distribution. Ideal candidates...Regulatory
- ...operations, engineering, quality, production, finance,... ...pharmaceutical, life science, biotech, food, and electronic... ...to budget and supporting cost optimization initiatives. Assure attainment of business... ...Ensure compliance with regulatory, safety, and quality standards...RegulatoryTemporary workLocal areaFlexible hours
$89k - $148k
...responsible for overseeing daily laboratory support operations, ensuring efficient service delivery, compliance with regulatory standards, and high‑quality support for laboratory functions. This... ..., and regulatory requirements such as GMP, GLP, and OSHA. Oversee lab inventory,...RegulatoryLocal area$75k - $85k
Company Overview GenScript Biotech Corporation (Stock Code: 1548.HK... .... Position Title: Media Specialist, Biosciences Location: Remote... ...experience) Key Responsibilities Support execution of paid media... ...follow internal brand guidelines, regulatory requirements, and scientific...RegulatoryRemote workRelocation$110k - $137k
...services, GENEWIZ, leads the way in providing superior data quality with unparalleled technical support to enable researchers around the world to advance... .../next generation sequencing, bioinformatics, and GLP regulatory services.How You Will Add ValueWe are seeking a...Regulatory- ...Description Summary The Quality Assurance Specialist I is a regular employee in a full-time exempt position... ...employee will be responsible for supporting Kashiv BioSciences Quality Assurance... ...Quality Management. Ensure adherence to GMP good documentation practices....Full timeWork at officeFlexible hours
$105k - $150k
...The Quality Assurance Specialist will support the Safety and Mission Assurance Services II (SMAS II) contract via a resident management office located in Springfield, NJ. RESPONSIBILITIES Perform Quality Assurance Specialist (QAS) inspection functions for space flight...Full timeContract workWork experience placementWork at officeFlexible hours- ...Position The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful... ...with local, global, and regulatory guidelines. The incumbent... ...6 years' experience in GMP environment/regulated industry... ...of equipment data quality systems. Strong verbal...RegulatoryWork at officeLocal area
- ...QA/QC Specialist, NJ Maryland Energy Advisors (MDEA) is a rapidly... ...energy management firm supporting many of the region's largest... ...play a key part in supporting quality assurance, operational oversight, and... ...meet program standards, regulatory requirements, and production...RegulatoryFor contractorsFor subcontractorWork at officeRemote work
- ...Compliance Ensure full compliance with GMP, FDA, HACCP, and all food safety... ...Partner with QA/QC to ensure product quality, consistency, and regulatory compliance Cross‑Functional Collaboration... ...plans clearly and proactively Support new product launches and ensure operational...Regulatory
- GenScript Biotech Corporation in Piscataway, NJ, is seeking a Direct Materials Procurement Lead to manage end-to-end sourcing... ...negotiate with suppliers to achieve cost savings while ensuring quality and regulatory compliance. The role requires cross-functional...Regulatory
$85k - $105k
...GenScript Biotech Corporation Founded in 2002 in New Jersey, GenScript Biotech Corporation... ...compliance audits to ensure full regulatory compliance with accurate filings and duties... ...provide customs guidance and operational support. Stay current with regulatory changes from...RegulatoryTemporary workWork at officeFlexible hours$70k - $96k
...New Jersey, is seeking an Analytical Systems Administrator to manage global documentation systems and ensure compliance with quality and regulatory expectations. This role requires a Bachelor's degree in Chemistry or a related field and knowledge of laboratory operations...Regulatory- ...clinical supply solutions firm in New Jersey is seeking an experienced Quality Assurance Specialist to oversee the quality of goods and services. The ideal candidate will ensure compliance with regulatory standards while performing regular inspections and implementing QA...Regulatory
- ...managing labor relations issues and enhancing union relationships to support business goals. The ideal candidate will have a Bachelor's... .... This position is critical to maintaining compliance with regulatory standards and fostering a productive work environment. #J-188...Regulatory
$103.56k - $125.5k
...leading the Label Management team, ensuring compliance with regulatory standards, and fostering a collaborative work environment. Ideal... ...should have a Bachelor's Degree and relevant experience in GMP and Quality compliance. The job includes night shifts from Wednesday to...RegulatoryNight shift
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!
- rn quality Westfield, NJ
- quality management nurse Westfield, NJ
- quality tech Westfield, NJ
- quality lead Westfield, NJ
- quality manufacturing Westfield, NJ
- quality equipment Westfield, NJ
- regulatory Westfield, NJ
- quality assurance representative Westfield, NJ
- lead qa Westfield, NJ
- quality assurance team leader Westfield, NJ

