QA Specialist I: Batch Release & Cleanroom GMP
$28.85 - $34 per hourVericel® Corporation
Vericel® Corporation is seeking a detail-oriented individual for an onsite role in Burlington, MA. This position involves crucial tasks including batch record review, label issuance, and inspection of final products within an ISO 7 cleanroom. Candidates with a High School degree/GED and essential GMP knowledge are preferred, with an hourly wage ranging from $28.85 to $34. The role emphasizes teamwork and offers opportunities for professional growth in a collaborative culture focused on patient care transformation. #J-18808-Ljbffr Vericel® Corporation
- ...QA/QC Specialist I A Few Words About Us Integrated Resources, Inc is a premier staffing... ...materials to ensure compliance with GMP and perform GMP release of IMP and to ensure compliance with... .... • Ensure that all appropriate batch related documents are available in order...SuggestedFor contractors
$28.85 - $34 per hour
...includes, but not limited to batch record review, media... ...product packaging and release activities. The... ...product within an ISO 7 cleanroom. Support day to day... ...Support projects as a QA resource. Identifies... ...Basic working knowledge of GMP regulations. Preferred...SuggestedHourly payFor contractorsWork at officeWeekend work$30 - $32 per hour
Status: Accepting Candidates About the role Support QA and manufacturing operations by ensuring compliance with GMP, FDA, and ISO requirements through batch record review, product release, and on-the-floor quality support. Key Responsibilities Review and approve batch...SuggestedHourly payWork at office$72.78k - $96.07k
...a qualified candidate for a pivotal role at their Chelsea, MA facility overseeing production activities and ensuring compliance with GMP standards. The position requires a bachelor's degree in a scientific discipline and at least 3-5 years of experience in a GMP environment...SuggestedNight shift- Alnylam Pharmaceuticals is seeking a Specialist in Quality Operations QA to provide on-site operational support at our Cambridge manufacturing facility... ...QA review and approvals, ensuring compliance with GMP regulations, and leading investigations during manufacturing...Suggested
$76k - $83k
...projects and daily GxP operations Issuance of Controlled Copies, Batch Records, Logbooks, Lab Notebooks, and Data Collection Forms.... ...management within a GxP environment, and minimum of 5 years working in a GMP environment is highly preferred Proficiency with MS Office,...Local area$88.7k - $120.1k
Overview The Specialist, Quality Operations QA is an experienced senior level position within... ...and approval for master batch records (MBRs), SOPs,... ...disposition activities for the release of API, DS and DSI SOP generation... ...operations experience in a GMP manufacturing facility...Full timeTemporary workLocal areaMonday to FridayFlexible hours$109.15k - $126.85k
...seeking an experienced Senior QA Specialist, RLT Manufacturing Operations... ...Specialist for Radioligand GMP Manufacturing Operations plays... ...are manufactured, tested, and released in full compliance with cGMP,... ...daily operations, supports batch review and release, manages deviations...$93k - $110k
...care). Position Summary Responsible for QA validation activities for equipment, facilities... ...support to QA Operations including batch record review and product disposition. Schedule... ..., facilities, and utilities including cleanrooms, HVAC systems, water systems (WFI, RO/DI)...For contractorsShift work$85k - $105k
Quality Assurance Specialist II, Device Engineering Terrestrial (formerly known as Vaxess) is... ...oversight, process validation readiness, and batch record/data review, aligned with ISO 1348... ..., as applicable to Phase I and GMP-ready manufacturing. ● Participate in Material...Work at office$65k - $113.75k
...media during the ship-stage of a release. Financial services... ...architect, business analysts, product specialists, developers and other project... ...in the Scrum team's QA methodology, innovate by researching... ...scripts for web, desktop, API, and batch applications. Proven...Temporary workFlexible hours- ...Quality Assurance Specialist Integrated Resources, Inc is a premier staffing firm recognized... ...Professional will work in the Internal QA team of Human Genetic Therapies Quality Assurance... ...reportable forums Work Order review Batch Record review of more complex process...
- ...Description & Requirements The Quality Assurance (QA) Associate II supports and assists with supporting and driving the Quality... ...CLEP) Familiarity with quality systems (e.g., ISO 9001, GCLP, GMP) preferred Understanding of laboratory workflows, including...Local areaFlexible hours
$50k - $60k
...looking for a talented and passionate Quality Assurance Associate (QA Associate) to join our team. The Quality Associate contributes to... ...troubleshoot real-time quality issues and ensure compliance with GMP and ISO standards Participate in cross-functional meetings as...Monday to Friday$43 - $45 per hour
...This role involves providing support for QA issues within the manufacturing suite and... ...and risks associated with all quality and GMP processes. The position requires running investigations... ...and document control. Experience in batch record review, CAPA, and deviation...Contract workTemporary work$76k - $83k
Ocular Therapeutix, Inc. is seeking a Quality Assurance Associate, Records Management, to handle electronic document management and support regulatory compliance. This position requires an Associate’s degree and a background in GxP environments, with at least 3 years of...$72.78k - $96.07k
...production activities including area clearance, issuance and review of batch records, and decisions on initiation of discrepancies. Oversight... ...(required). Minimum of 3-5 years of progressive experience in a GMP environment (required). Minimum of 1 year of quality assurance...$53 per hour
...summary: We are seeking a high-caliber QA Investigation Reviewer (Quality Assurance... ...review, guidance, and formal approval of GMP investigations, deviations, and Out-of-Specification... ...patient safety, and driving timely batch disposition in a fast-paced commercial...Hourly payContract workTemporary workWork experience placement$60k - $110k
Quality System Specialist/Senior Quality System Specialist Terrestrial (formerly known as Vaxess... ...) to ensure compliance with applicable GMP/GLP standards. This position focuses on... ...that controlled documents, such as SOPs, batch records, and specifications, are accurate...$115k - $140k
A medical diagnostics company in Bedford, MA is looking for a Senior Quality Systems Specialist I to oversee compliance with quality management systems. The role involves managing CAPA processes, facilitating audits, and supporting training programs. Ideal candidates will...Remote work- Vericel® Corporation is seeking a QA Validation Specialist in Burlington, MA to manage validation activities ensuring compliance with cGMP regulations. You will have responsibilities such as reviewing protocols, supporting equipment qualifications, and overseeing maintenance...
- ...experienced, detail-oriented, and proactive Quality Assurance (QA) Specialist or Manager with a strong background in auditing regulated... ...g., EMA, ICH, ISO). Verify that study documentation (e.g., batch records, raw data, final reports) meets regulatory requirements...Full time
- ...Lancesoft Job Details: Title : Quality Assurance Specialist Location : Lexington, MA Duration: 3 years Contract... ...• Plan, design, deploy, maintain and troubleshoot related to QA tools like Tricentis TOSCA and Impact Analysis/Live Compare tool...Contract workApprenticeshipLocal area
- ...technical assessments of systems engineering, Quality Assurance (QA), lessons learned, technology, production and programmatic (cost... ..., instructions and standard operating procedures prior to release for correctness to technical standards. Act as the voice of the...Work experience placementWork at officeRelocation package
$115k - $140k
...Number ICIMS-2026-10105 Job function QA&RA Job type Full-time Location Werfen... ...System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other... ...Functions: The Senior Quality Systems Specialist I will be expected to support all...Full timeWork at officeRemote workWorldwideShift work- ...Monitoring/Aseptic Technique Additional Desirable Qualifications Skills and Knowledge: Familiarity with Good Manufacturing Practices (GMP) Rev 7/22/2019 Bard Internal Job Description: Advancing the Delivery of Healthcare Experience with Microsoft Word and Excel...Contract workWork at officeDay shift
- ...standards. Review and assess quality documentation, including batch records, validation reports, and regulatory submissions. Collaborate... ...role. Experience in Product Quality Assurance within a GMP environment, including aseptic manufacturing. Proficiency with...Weekly payContract workTemporary workWorldwideFlexible hours
$89k - $148k
...problem resolution. Organized, detail oriented and self-motivated. Experienced with supporting pharmaceutical and/or medical device GMP compliance regulatory inspections. Preferred Qualifications Good planning and project management skills. Good verbal,...Local areaWorldwide3 days per week$20 - $26.92 per hour
...Record (EHR). Assists with expediting the backlog of problematic batches, identifies and indexes documents into appropriate electronic... ...necessary. Shares knowledge with BILH colleagues as an EHR specialist by answering EHR related questions and providing correct...Work at office$20 - $26.92 per hour
Beth Israel Lahey Health is seeking a qualified HIM Specialist to ensure data quality and integrity within the Electronic Health Record system. The role involves monitoring HIM QC procedures, verifying patient data, and participating in workflow projects. Candidates should...Hourly payWork at office
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