Biologics QA Specialist - cGMP Compliance & Release
Kashiv Biosciences LLC
Kashiv BioSciences, LLC is seeking an MQA Specialist I, II, or III to ensure cGMP compliance across manufacturing, labs, and quality systems. You will review materials, release batches, and support audits with cross-functional teams in a biologics environment. The role emphasizes attention to detail, documentation accuracy, and collaborative problem solving to drive continuous improvement and safe, compliant product manufacture. #J-18808-Ljbffr Kashiv Biosciences LLC
- ...Legend Biotech in Raritan, NJ seeks a QA Shop Floor Specialist to oversee quality during autologous CAR-T production in a cGMP cleanroom. You will ensure compliance with GDP, review SOPs, and support batch release in SAP for in-house reagents. The role requires 0-2+ years...SuggestedWeekend work
$83.71k - $109.87k
...the treatment of multiple myeloma. QA Laboratory Compliance Specialist III Legend Biotech is seeking a QA Laboratory... ...Control Departments including QC Release, QC IPL, QC Micro, QC Lab Services... ...management process. Knowledge of cGMP/cGLP regulations and FDA/EU guidance...SuggestedPermanent employmentFull timeTemporary workFor contractorsWork experience placementWork at officeLocal areaImmediate startWorldwideFlexible hours$70k - $75k
...The Quality Assurance Specialist is a regular employee... ...the facility are in compliance with cGMP requirements and company... ...documentation and releasing material, reviewing deviations... ...experience for QA I (0 to 2 years or... ...plus years) in a cGMP biologics/biosimilars...SuggestedFull timeWork at officeLocal areaFlexible hours$68.05k - $95.54k
...Biotech is seeking a QA Shop Floor Specialist as part of the Quality... ...in a controlled cGMP cleanroom environment... ...highest standards in compliance within company policies... ...batch review & material release in SAP for in‑house... ...exposure to and handling of biological materials and...SuggestedPermanent employmentFull timeTemporary workFor contractorsWork experience placementLocal areaImmediate startWorldwideFlexible hoursWeekend work$75.97k - $99.71k
...Biotech is seeking a QA Shop Floor Specialist II/III as part of the... ...operation in a controlled cGMP cleanroom environment... ...highest standards in compliance within company... ...batch review & material release in SAP for In-house... ...exposure to and handling of biological materials and...SuggestedWork experience placementImmediate startWorldwideFlexible hoursWeekend work- Role Overview The QA Shop Floor Specialist is an exempt level position... ...in a controlled cGMP cleanroom environment... ...maintaining high standards in compliance with company policies... ...review and material release in SAP for in-house... ...to and handling of biological materials and...Local areaImmediate startWeekend 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...
- Legend Biotech is seeking a QA Laboratory Compliance Specialist III in Raritan, NJ. This role involves quality oversight over Quality Control Laboratories... ...2 years of relevant experience, and strong knowledge of cGMP. Success in this position requires excellent...
- Isotopia USA, a global biotech company, seeks a Quality Assurance Administrative Specialist at our Westfield, NY site. You will manage QA document control, ensure cGMP compliance, and support regulatory filings, with a focus on accurate records and efficient processes....
$70k - $75k
...World through Accessible Biologics: Kashiv BioSciences,... ...Assurance (MQA) Specialist I, II, and III is responsible... ...and ensuring compliance with current Good Manufacturing Practices (cGMP), Company procedures,... ...operations, raw material release, batch record review,...Work at officeLocal areaFlexible hours- ...authenticity, origin, traceability and purity of biological substances and products. Job Description Job... ...minimal supervision, the Quality Assurance Specialist III will ensure systems and processes are in a state of compliance with regard to internal, regulatory, and...Full timeContract workFor subcontractorMonday to Friday
- ...manufacturer, is seeking a Quality Support Specialist to own investigations of product and process deviations and ensure compliance with Food Safety guidelines, GMPs and SOPs.... ...drives 5S and continuous improvement projects, collaborating with QA teams to #J-18808-Ljbffr...
- Legend Biotech US is seeking a QA Shop Floor Specialist to provide quality oversight... ...manufacturing floor within a controlled cGMP cleanroom environment. The role ensures compliance with GDP, SOPs, and regulatory... ...while supporting batch release and material control in SAP....
$69.5k - $102.35k
Johnson & Johnson, QA Specialist II (1 of 2) - Application via WayUp Join to apply for the Johnson... ...more at As a QA Specialist II you will release incoming patient apheresis material for... ...related Advanced Therapy products in a cGMP manufacturing facility. Perform review...Contract workTemporary workPart timeLocal areaImmediate startAfternoon shift$65k - $104.65k
...three Quality Assurance Incoming Specialist II. This position will be... ...you will be providing quality releases of materials related to the... ...viral vectors in a controlled cGMP environment. You will act as... ...procedures to increase quality and compliance and champion increased...Local areaImmediate startShift workDay shift- MEDVACON in Edison, New Jersey is seeking contractors for cGMP Quality Compliance Validation roles in a pharmaceutical setting. The company collaborates with leading pharmaceutical firms and offers positions available for W2 or direct 1099. Candidates with prior consulting...Permanent employmentContract workFor contractorsRemote work
- FOCO is a world-leading manufacturer of sports and entertainment merchandise. This Quality Assurance & Compliance Associate role supports U.S.-based quality operations, ensuring products meet safety and compliance standards before shipment. Join FOCO’s Supply Chain Quality...
- ...team! The Opportunity We're looking for a Quality Assurance & Compliance Associate to join our Supply Chain Quality & Production team. This... ...submissions, and inspection documents for accuracy Maintain QA/QC logs, trackers, and documentation in digital systems Assist...Work at officeWorldwide
- Legend Biotech is seeking a QA Laboratory Compliance Specialist III based in Raritan, NJ. In this role, you will provide oversight in Quality Control Laboratories, ensuring compliance with quality standards and regulations. The ideal candidate will have a Bachelor’s Degree...
- ...Quality Compliance Specialist New Brunswick, New Jersey, United States Orion Innovation is a... ...deliverables, review and approval as a QA 4) Ideal candidate would have prior experience... ...such as incident, problem, change, release, etc.; Ensure adequate and timely...
- Amneal Pharmaceuticals LLC seeks an NOI Investigations Specialist to enhance product quality and compliance through thorough investigations of quality events.... ...findings in a regulator-ready format to support release decisions and continuous improvement across manufacturing...
- Sun Pharma is seeking a highly motivated and detail-oriented Compliance Associate II to support and strengthen our Quality Management System... ..., supporting inspection readiness, and ensuring adherence to cGMP requirements. As a key member of the Quality organization, you...
- USPL is seeking a Specialist in Quality Assurance Documentation to manage writing, distribution, collection... .... You will help ensure SOP and GMP compliance and adherence to 21 CFR Part 111 and 117, reporting to QA Manager with dotted line to Head of QA. You will...Work at office
- ...Specialist, QA OperationsSpecialist, QA Operations, is responsible for quality oversight of Cell... ..., standards, procedures, and Global cGMP requirements. This position reports to the... ...Triage, Packout oversight and performance of release-to-market, ensuring accurate and timely...
- ...Assurance Administrative Specialist Isotopia is a global biotech... ...as a key coordinator for QA documentation and records management, compliance with current Good Manufacturing Practices (cGMP), FDA regulations (21 CFR... ...processes, such as with release of incoming raw materials...Shift work
$28 - $31 per hour
...requirements. This role assists with batch release activities, product complaints, recalls... ...site and coordinate with corporate QA for investigations. Support Drug Product... ...Bachelor's degree in pharmacy, Chemistry, Biology or Microbiology is preferred ~3 years of...Contract workWork at officeDay shift- ...Routes final label for review and approval accordingly. Participates in assigned training including cGMP and safety training. Ensures regulatory, cGMP, GDP compliance of activities in assigned areas of responsibility. Reports any deviations to the appropriate management...Full timeWork from home
- ...is looking for a Quality Assurance Incoming Specialist II based in Raritan, NJ. The role involves overseeing the quality and compliance of materials for CAR-T production in a... ...manufacturing setting. Demonstrated knowledge of cGMP regulations and strong interpersonal skills...
- 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... .... Responsibilities include ensuring compliance, reviewing SOPs, and supporting manufacturing...Afternoon shift
$81.27k - $106.67k
...treatment of multiple myeloma. Position QA Change Control Specialist II - Quality team, Raritan, NJ Role... ...policies, quality systems, and cGMP requirements. Review change controls... ...in quality assurance, manufacturing compliance, clinical quality, or cell therapy....Permanent employmentContract workTemporary workWork experience placementWork at officeLocal areaWorldwideFlexible hoursShift work
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