QA Specialist, Biopharma — Impactful Quality & Compliance
PharmaEssentia U.S.A.
PharmaEssentia USA in Burlington, MA, is seeking a Quality Assurance Specialist to manage the product quality system, review batch records, deviations, CAPA, complaints, recalls, and DSCSA compliance. You will partner with cross-functional teams and HQ QA to ensure timely, compliant product release. The role requires a Bachelor's degree in life sciences and 3+ years in aGxP QA, with strong knowledge of FDA regulations, ICH guidelines and DSCSA. On-site work five days a week. #J-18808-Ljbffr PharmaEssentia U.S.A.
$81.15k - $101.96k
...the chance to make a real impact on the lives of others,... ...improve both health and quality of life for patients... ...The Quality Assurance Specialist reports to the senior manager of QA and will play a key role... ...Supply Chain Security Act) compliance together with supporting...SuggestedFlexible hoursShift workAfternoon shift- What You’ll DoThe Senior Quality Assurance Specialist provides quality assurance oversight across CMC development, Quality Control, Analytical... ...Development, manufacturing, and supply chain activities, ensuring compliance with global regulatory requirements and internal quality...SuggestedFull timeContract workImmediate start
$85.4k - $158.6k
Reporting:Associate Director, Quality AssuranceDescription: We are... ...experienced Senior Quality Assurance Specialist, to join Mariana’s Quality... .... The Senior QA Specialist plays a critical role... ...tested, and released in full compliance with cGMP, radiation safety regulations...Suggested- ...The Quality Assurance Specialist will actively contribute to the implementation and maintenance of the Quality Systems Manual and conduct GMP compliance audits as directed. The QA Specialist will have oversight of and involvement in, GMP compliance for production of Clinical...SuggestedContract work
- ...of Lancesoft Job Details: Title : Quality Assurance Specialist Location : Lexington, MA Duration: 3... ...design, deploy, maintain and troubleshoot related to QA tools like Tricentis TOSCA and Impact Analysis/Live Compare tool for SAP. • Analysis of...SuggestedContract workApprenticeshipLocal area
- ...103-129/hr DOESeeking an experienced Principal Clinical Quality Assurance Specialist to provide expert guidance and hands-on support for Good... ...quality oversight for clinical trials, including protocol compliance, investigator site oversight, trial master file quality,...Contract work
$85k - $105k
Quality Assurance Specialist II, Device Engineering Location: Woburn, MA (relocating to a new facility... ...continuous improvement initiatives Ensure compliance with ISO 13485, FDA Quality System... ...Opportunity to make a meaningful impact during clinical development and commercializationEOE...Relocation$94k - $150k
...Supplier Quality Specialist The Supplier Quality Specialist supports supplier quality management... ...data, track performance, and support compliance with quality and regulatory... ...of role Your role: • The greater impact of this role. • Detail elements of the...Full timeWork at officeLocal areaWork visaRelocation package3 days per week$110k - $120k
...surgery, where precision, reliability, and quality matter every time. Because engineering,... ...Role As a Senior Quality Systems Specialist at Lexington Medical, you will be the hands... ...to keep product quality and QMS compliance on track as processes and products change...- Vericel Corporation, a leader in advanced cell therapies, seeks a QA-focused professional for day-to-day batch record review, labeling, archiving, and final product inspection in our Burlington, MA facility. You'll gown into ISO 7 clean rooms and support release activities...RelocationWeekend work
$63.65k - $92.57k
...for ensuring the accuracy and quality of billing information. Reviews... ...audits records to maintain compliance with regulatory standards and... ...other actionable insights to the QA, Training, and Operations Leadership... .... Hold a hand. Help people. Impact the world. Mass General...Remote workShift work$28.85 - $34 per hour
...and final product. Support projects as a QA resource. Identifies deficiencies and works... ...electronic batch records, ERP systems and Quality Management Systems (Examples: TrackWise and... ...with opportunities to expand your impact. Collaborative Culture: Work alongside a team...Hourly payFor contractorsWork at officeMonday to FridayWeekend work- Job DescriptionDescriptionThe Quality Assurance Professional will work in the US External QA team responsible for Contract Manufacturing (CMO) and Contract Test... ...commercial biologics products. Interfacing CMO for site compliance documentation, quality systems review (deviations...Contract workFlexible hours
$80k - $140k
Quality Assurance Engineer - AI Testing, Charles River Development/State Street AlphaWhy this... .... This role is ideal for a mid-level QA professional who combines strong software... ...exception handling, and user experience impacts.Design and execute tests for AI guardrails...Full timeTemporary workFlexible hours- ...Quality Assurance Specialist Integrated Resources, Inc is a premier staffing firm recognized as one... ...Professional will work in the Internal QA team of Human Genetic Therapies... ...Responsibilities include support of Commercial QA Compliance and Operations. Deviation Review and...
- ...QA Specialist Perform the QA review/approval of analytical documentation: Analytical method validation protocols and reports for in-... ...preparation for Process Performance Qualification activities Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to...
$72k - $91.5k
...Quality Control Specialist Lexington, MA Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical... ...trusted and empowered to make a real impact—shaping the future of medicine while... ..., accuracy, traceability, and compliance with applicable procedures...Contract workWork at office$20 - $25 per hour
...Description Overview Now Hiring: Quality Assurance Specialist – Food Manufacturing ???? Lowell, MA... ...affect production Help maintain compliance with food safety, quality, and manufacturing... .../Spanish is a plus Make an Impact on Product Quality Every product...Full timeImmediate startDay shift$88.43k - $125k
...Quality Control SpecialistAs a Quality Control Specialist at MKS, you will partner with cross-functional teams, including Engineering, Operations, Sales, internal... ...report to the Sr. Quality Manager.You Will Make an Impact By:Conducting routine process auditsSupporting MRB...Work at officeVisa sponsorshipWork visaRelocation package$88.43k - $125k
...Full time R21874 A Day in Your Life at MKS: As a Quality Control Specialist at MKS, you will partner with cross-functional teams, including... ...report to the Sr. Quality Manager. You Will Make an Impact By: Conducting routine process audits Supporting MRB...Permanent employmentFull timeWork at officeVisa sponsorshipWork visaRelocation package$107.1k - $138.6k
...Senior Quality Systems Specialist eGenesis is a clinical-stage... ...will be supporting the QA team to implement... ...highly visible and impactful position that will require... ...to enhance compliance and improve method and... ...the life sciences or biopharma areas with 5+ years...$100k - $115k
...manufacturing operations, the Senior Quality Assurance Specialist champions collaborative day to day floor... ...Oversee and provide regulatory compliance guidance during on-the-floor manufacturing... ...in batch disposition activities. QA support of drug product aseptic fill...Live inVisa sponsorshipShift work- ...Description Job Description CMC QA ASSOCIATE Location; Bedford... ....) to confirm the appropriate quality as well as compliant controls... ...and determination of product impact, root cause, and corrective... .... Expert knowledge of cGMP compliance regulations and industry...Contract workInterim roleLocal area
- Mass General Brigham Incorporated is seeking an experienced QA auditor for surgical coding at our Somerville, MA site. You will audit... ..., delivering regular performance reports, and maintaining high-quality standards in a collaborative, fast-paced environment. #J-18808-...Remote job
$84.3k - $126.5k
...Burlington, MA is hiring a Service Quality Specialist. This position is part of... ...:QMS Strategy & Compliance: Serve as the primary focal... ...years of Quality Assurance (QA) experiencePreferred Qualifications... ...inclusion and belonging that impacts millions and empowers everyone...Local area- Position Summary As PASCALL scales its FDA-cleared EEG platform and expands the quality function beyond a single QA resource, we need a Quality Officer to own day-to-day execution of the Quality Management System (QMS), keeping documentation, audits, and change control...Remote workWorldwide
- ...Israel Lahey Health (BILH) is seeking a Health Information Management Quality Control Specialist to provide continuous quality review of electronic medical record functions and ensure HIM regulatory compliance. Under the supervision of the Director of Health Information...
$65k - $80k
...customers, and our dedication to innovation and quality. We’re passionate about providing... ...Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards... ...Essential Functions: The QS Specialist I will be expected to support all activities...Work at officeWorldwideShift work- ...QA Documentation Associate A Few Words About Us Integrated Resources, Inc is a premier... ...centers on delivering only the best quality talent, the first time and every time. We... ...training, participate in internal/external compliance audits. Interfacing with key Quality,...
$111k - $123k
...information, please visit .Department: Quality AssuranceReports to: VP,... ...Senior Quality Engineering Specialist provides hands-on operational... ..., escalating delays and compliance risks promptly.Supplier Quality... ...patients first and make meaningful impact together.U.S. Pay Range$111,0...Full timeTemporary workRemote work
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