QA Oversight Specialist - cGMP & Audit Readiness
TechDigital Group
Join a forward-thinking company as a Quality Assurance Specialist, where you will oversee critical quality processes in a dynamic environment. This role involves managing CMO oversight, ensuring compliance with GMP standards, and preparing for regulatory audits. You will play a vital role in maintaining product quality and safety, collaborating with various teams to implement business objectives. Ideal candidates will have a strong background in Quality Assurance within the pharmaceutical or biotechnology sectors, with excellent attention to detail and communication skills. This is a fantastic opportunity to contribute to high-quality standards and make a significant impact in the industry. #J-18808-Ljbffr TechDigital Group
$69.5k - $102.35k
Johnson & Johnson, QA Specialist II (1 of 2) - Application via... ...Advanced Therapy products in a cGMP manufacturing facility.... ...regularly scheduled oversight of manufacturing... ...inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity...SuggestedContract workTemporary workPart timeLocal areaImmediate startAfternoon shift- The Quality Assurance Specialist will provide Quality oversight to the CMO with the ability to... ...support Quality Reviews and QA Shop Floor manufacturing... ...and other regulatory agency audits and inspections. Provides... ...confidence that the cGMP requirements are completed...Suggested
- ...Township, New Jersey is seeking a Quality Assurance Specialist. This role involves inspecting, sampling, and... ...testing incoming materials, ensuring compliance with cGMP regulations, and providing quality assurance oversight. The ideal candidate will have a Bachelor’s...SuggestedWork at office
$38 - $40 per hour
...Title: Quality Assurance Specialist Job Description We... ...role provides hands-on QA support on the... ...of product quality and cGMP compliance. The ideal candidate... ...documentation, and floor oversight—particularly within... ...documentation and release readiness. Identify and help...SuggestedContract workTemporary work- ...QA Shop Floor Specialist II Legend Biotech is a global biotechnology company... ...responsible for the floor quality oversight of the production of... ...operation in a controlled cGMP cleanroom environment. This... ...through spot checks/internal audits. Collaborate with site...SuggestedWork experience placementImmediate startWorldwideFlexible hoursWeekend workDay shift
- A biotechnology company in New Jersey seeks a QA Change Control Specialist II responsible for quality oversight in a cell therapy manufacturing facility. Applicants... ...and a minimum of two years' experience within a cGMP environment. Strong communication, analytical problem...
$81.27k - $106.67k
...treatment of multiple myeloma. Position QA Change Control Specialist II - Quality team, Raritan, NJ Role... ...with responsibilities for quality oversight of the change control process within... ...safety policies, quality systems, and cGMP requirements. Review change controls...Permanent employmentContract workTemporary workWork experience placementWork at officeLocal areaWorldwideFlexible hoursShift work$75.97k - $99.71k
...Legend Biotech is seeking a QA Shop Floor Specialist II/III as part of the... ...responsible for the floor quality oversight of the production of... ...operation in a controlled cGMP cleanroom environment. This... ...through spot checks/internal audits. Collaborate with site personnel...Work experience placementImmediate startWorldwideFlexible hoursWeekend work- Legend Biotech US is seeking a QA Shop Floor Specialist in Raritan, New Jersey, to provide quality oversight in the production of CAR-T products. This exempt-level position involves maintaining compliance in a cGMP cleanroom and supporting manufacturing activities. You...
- Kashiv BioSciences LLC in Piscataway Township, NJ is looking for a Quality Assurance Specialist responsible for ensuring compliance with cGMP regulations and quality event documentation. The role requires 0-5 years of experience in a pharmaceutical manufacturing environment...Work at office
- Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality... ...responsible for floor quality oversight of the production of autologous... ...operation in a controlled cGMP cleanroom environment. This... ...spot checks/internal audits. Collaborate with site personnel...Permanent employmentFull timeFor contractorsLocal areaImmediate startFlexible hoursWeekend workDay shift
- ...Job Summary: Under minimal supervision, the Quality Assurance Specialist III will ensure systems and processes are in a state of compliance... ...(client, regulatory agencies, accreditation bodies, etc.) audits. Participate in all aspects of Quality Assurance to ensure regulatory...Full timeContract workFor subcontractorMonday to Friday
$65k - $104.65k
...three Quality Assurance Incoming Specialist II. This position will be... ...viral vectors in a controlled cGMP environment. You will act as... ...timely closure Provide Quality Oversight to Warehouse for cGMP... ...through spot checks/internal audits Support execution of technical...Local areaImmediate startShift workDay shift- Looking for animal health GCP auditing experience. • Animal health GLP auditing experience. Job Title: Quality Specialist- II -Hybrid Job Location: Rahway NJ Duration: 2 years Provide QA oversight for a Global Research & Development organization. Serve as the Quality...
- Legend Biotech in Raritan, New Jersey, is hiring a QA Shop Floor Specialist. This role involves quality oversight in the production of autologous CAR-T products, ensuring compliance within cGMP standards. The ideal candidate holds a Bachelor’s degree in Life Sciences or...
- Merck & Co. is seeking a QA Shop Floor Specialist in Raritan, NJ for quality oversight during the production of CAR-T products in a cGMP cleanroom environment. Responsibilities include ensuring compliance with company and regulatory standards, reviewing documentation, and...
- ...Healthcare Solutions LLC is looking for a full-time Quality Specialist in Edison, NJ. This role primarily supports the cGMP compliant quality program for pharmaceutical storage and involves managing quality audits, documentation, and vendor evaluations. Ideal candidates...Full timeWork at office
- ...large development pipeline. We are looking for a Documentation Specialist to join our Piscataway NJ Quality Management team. Job Type: Full... ...batch record review To train cross functional team on GDP and cGMP To perform additional work assigned by supervisor as and when...Full timeLocal areaFlexible hours
- ...provider in Edison, NJ is hiring a Quality Specialist to support the compliance program for... ...involves managing MasterControl, supporting audits, and developing quality policies.... ...communication skills and familiarity with ISO or cGMP standards are essential. The position...
$93.46k - $122.67k
Job Overview QA Validation Specialist III role at BioSpace, based in Raritan, NJ.... ...position responsible for quality oversight of validation and... ...qualified equipment/systems (audit trails, user groups, system... ...policies, quality systems, and cGMP requirements. Drive continuous...Work at officeFlexible hours$127.31k - $167.1k
...Legend Biotech is seeking a Sr. QA Validation Specialist, CSV & Equipment as part of... ...for providing quality oversight over the validation and qualification... ...equipment/systems (audit trails, user groups, system... ...policies, quality systems, and cGMP requirements. Drive continuous...Permanent employmentFull timeTemporary workFor contractorsWork experience placementWork at officeLocal areaWorldwideFlexible hours- ...experienced Quality Assurance Specialist to join our team. In this... ...internal JRS standards. The QA Specialist ensures that all... .... Participate in internal audits, customer audits, vendor qualifications... ...Supply Chain Quality Oversight Perform QA review and...Worldwide
- ...SUMMARY: The Quality Assurance Specialist II is a regular employee in a... ...are in compliance with cGMP requirements and company policies... ...assurance walk-through audits of manufacturing, laboratory and... ...Direct experience in manufacturing QA support (sampling, room/line...Full timeWork at officeFlexible hours
$96.27k - $126.35k
Legend Biotech is seeking a QA Shop Floor Specialist in Raritan, New Jersey, responsible for overseeing production quality for cell therapy clinical... ...with cross-functional teams and adherence to strict cGMP standards. Candidates should hold a Bachelor’s degree in Life...- Kashiv Biosciences LLC is seeking a Quality Assurance Specialist II in Piscataway, NJ. This full-time role involves... ...managing the quality system, ensuring compliance with cGMP requirements, and conducting quality audits. The ideal candidate should possess a 4-year degree...Full time
- JUPITER RESEARCH SERVICES INC is seeking a Quality Assurance Specialist to ensure compliance in clinical trial materials management. This role involves overseeing quality processes from receipt to distribution while collaborating with cross-functional teams. The ideal...
- ...healthcare company is looking for a Quality Assurance Incoming Specialist II based in Raritan, NJ. The role involves overseeing the quality... ...a regulated manufacturing setting. Demonstrated knowledge of cGMP regulations and strong interpersonal skills are essential for success...
- Position Senior QA Specialist I, Drug Substance (DS) Location: Cranbury, NJ Responsibilities Perform... ...records to ensure compliance with cGMP and data integrity expectations. Author,... ...requirements. Provide QA support during internal audits, customer audits, and FDA inspections by...Work experience placementWork at officeShift workWeekend work
- A biotechnology company seeks a QA Shop Floor Specialist responsible for overseeing quality in CAR-T cell therapy production in a cGMP cleanroom. Ideal candidates will have a Bachelor's degree in Life Sciences or Engineering and 0-2 years of relevant experience. Responsibilities...Afternoon shift
- ...biotechnology company in Raritan, New Jersey, is seeking a QA Shop Floor Specialist II/III to oversee floor quality in the production of... .... Responsibilities include ensuring compliance with cGMP, supporting internal audits, and collaborating with teams on quality issues. The...
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