Pharma QA Specialist - Hybrid Role, Impact & Compliance
pharmaessentiausa
PharmaEssentia USA in Burlington, MA is seeking a Quality Assurance Specialist to manage the product quality system, review batch records, deviations, CAPA, recalls, and DSCSA compliance. The role ensures proper documentation, timely responses, and cross-functional support for quality initiatives. Responsibilities include producing quality metrics, leading investigations with internal and external stakeholders, and supporting supplier audits and regulatory inspections to maintain compliant #J-18808-Ljbffr pharmaessentiausa
$81.15k - $101.96k
...chance to make a real impact on the lives of... ...OverviewThe Quality Assurance Specialist reports to the senior manager of QA and will play a key role in managing the... ...Chain Security Act) compliance together with supporting... ...Massachusetts, and follows a hybrid work model requiring...SuggestedFlexible hoursShift workAfternoon shift3 days per week- What You’ll DoThe Senior Quality Assurance Specialist provides quality assurance oversight... ...manufacturing, and supply chain activities, ensuring compliance with global regulatory requirements and internal quality standards. In this role, you serve as a subject matter expert in...SuggestedFull timeContract workImmediate start
- ...Details: Title : Quality Assurance Specialist Location : Lexington, MA... ...Duration: 3 years Contract This is HYBRID job Responsibilities include but... ...and troubleshoot related to QA tools like Tricentis TOSCA and Impact Analysis/Live Compare tool for SAP....SuggestedContract workApprenticeshipLocal area
- ...: Waltham, MassachusettsCompany: Planet Pharma GroupContact: ApplicationsEmail: applications... ...*depending on expThe Clinical Quality Specialist, under the direction of the CQA... ...Quality and their operations in ensuring compliance of clinical studies, vendor management,...Suggested
- ...MassachusettsCompany: Planet Pharma GroupContact: ApplicationsEmail... ...Clinical Quality Assurance Specialist to provide expert guidance and... ...Quality, this contract role will serve as a trusted partner... ...clinical trials, including protocol compliance, investigator site oversight,...SuggestedContract work
- ...Description Job Description CMC QA ASSOCIATE Location; Bedford... ...product quality. In this role, in collaboration with key... ...and determination of product impact, root cause, and corrective and... .... Expert knowledge of cGMP compliance regulations and industry practices...Contract workInterim roleLocal area
$100k - $115k
...Senior Quality Assurance Specialist champions collaborative... ...disposition. This role is accountable for all... ...and provide regulatory compliance guidance during on-the-... ...disposition activities. QA support of drug product... ...relevant GMP experience in pharma/biotech company,...Live inVisa sponsorshipShift work- ...Description• The Quality Assurance Professional will work in the Internal QA team of company's Human Genetic Therapies Quality Assurance... ...manufacturing on behalf of company.• Support of Commercial QA Compliance: Deviation Review and Trending, CAPA Review and Trending.•...
$63.65k - $92.57k
...and audits records to maintain compliance with regulatory standards and... ...other actionable insights to the QA, Training, and Operations... ...'s degree preferred. Can this role accept experience in lieu of a... ...disease. Hold a hand. Help people. Impact the world. Mass General...Remote workShift work$85k - $105k
Quality Assurance Specialist II, Device Engineering Location: Woburn,... ...Onsite 5 days/week with future hybrid flexibility following... ...improvement initiatives Ensure compliance with ISO 13485, FDA Quality System... ...to make a meaningful impact during clinical development and...Relocation$94k - $150k
...SpecialistThe Supplier Quality Specialist supports supplier quality... ...Working cross-functionally, this role helps maintain supplier data,... ...performance, and support compliance with quality and regulatory requirementsYour... ...roleYour role:• The greater impact of this role.• Detail...Full timeWork at officeLocal areaImmediate startWork visaRelocation package3 days per week$85.4k - $158.6k
...Senior Quality Assurance Specialist, to join Mariana’s Quality... .... The Senior QA Specialist plays a critical role in ensuring that radiopharmaceutical... ...tested, and released in full compliance with cGMP, radiation... ...Requirements/Skills:Position is a hybrid role with 4 days a week...$80k - $140k
...River Development/State Street AlphaWhy this role is important to usThe team you will be... ...confidence. 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- ...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...Contract work
$72k - $91.5k
...Quality Control Specialist Lexington, MA Kiniksa Pharmaceuticals... ...and empowered to make a real impact—shaping the future of... ...and Quality Systems. This role is based in our Lexington, MA... ...accuracy, traceability, and compliance with applicable procedures...Contract workWork at office$20 - $25 per hour
...Now Hiring: Quality Assurance Specialist – Food Manufacturing ????... ..., you'll play an important role in monitoring product quality... ...production Help maintain compliance with food safety, quality, and... ...Spanish is a plus Make an Impact on Product Quality Every product...Full timeImmediate startDay shift$28.85 - $34 per hour
...release of intermediate and final product. Support projects as a QA resource. Identifies deficiencies and works with cross... ...part of a growing organization with opportunities to expand your impact. Collaborative Culture: Work alongside a team of dedicated professionals...Hourly payFor contractorsWork at officeMonday to FridayWeekend work- 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
$88.43k - $125k
...Quality Control SpecialistAs a Quality Control Specialist at MKS, you will partner with cross-... ...our processes and shipments. In this role, you will support day-to-day quality activities... ...the Sr. Quality Manager.You Will Make an Impact By:Conducting routine process...Work at officeVisa sponsorshipWork visaRelocation package$88.43k - $125k
...Your Life at MKS: As a Quality Control Specialist at MKS, you will partner with cross-... ...throughout our processes and shipments. In this role, you will support day-to-day quality... ...Sr. Quality Manager. You Will Make an Impact By: Conducting routine process audits...Permanent employmentFull timeWork at officeVisa sponsorshipWork visaRelocation package$84.3k - $126.5k
...unimaginable with us. This role does not offer... ...hiring a Service Quality Specialist. This position is part... ...Responsibilities:QMS Strategy & Compliance: Serve as the primary... ...of Quality Assurance (QA) experiencePreferred... ...inclusion and belonging that impacts millions and empowers...Local area$20 - $26.92 per hour
...Management, the Health Information Management Quality Control Specialist provides continuous quality review of electronic medical record... ...practice and Health Information Management (HIM) regulatory compliance. Job Description Follows HIM QC error monitoring procedures and...Hourly payWork at officeShift work- ...DescriptionDescriptionThe Quality Assurance Professional will work in the US External QA team responsible for Contract Manufacturing (CMO) and Contract... ...of commercial biologics products. Interfacing CMO for site compliance documentation, quality systems review (deviations, CAPA, Change...Contract workFlexible hours
- ...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...
- LightForce Orthodontics is seeking a VP of Quality & Regulatory to build scalable systems, lead the global quality function, and serve as senior voice on product quality, patient safety, and regulatory strategy. You will influence ELT decisions and shape the company’s path...
- ...cleared EEG platform and expands the quality function beyond a single QA resource, we need a Quality Officer to own day-to-day execution... ..., science-based anesthesia care to all patients. Work Location: Hybrid remote in Cambridge, MA 02139 #J-18808-Ljbffr Pascall Systems,...Remote workWorldwide
$110k - $120k
...the process and the decisions behind it. About the Role As a Senior Quality Systems Specialist at Lexington Medical, you will be the hands-on owner... ...Regulatory, and Manufacturing to keep product quality and QMS compliance on track as processes and products change. Keep...- ...Kinikska Pharmaceuticals seeks a Quality Control Specialist to coordinate GMP stability programs in Lexington, MA. The role involves managing stability data tracking, collaborating with contract laboratories, reviewing laboratory results, and supporting shelf-life determinations...Contract work
$65k - $80k
...Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards... ...Accountabilities Essential Functions: The QS Specialist I will be expected to support all... ...The annual base salary range for this role is currently $65,000 to $80,000. Individual...Work at officeWorldwideShift work$111k - $123k
...SummaryThe Senior Quality Engineering Specialist provides hands-on operational... ...and inspection-ready.The role also conducts risk-based... ...providers, escalating delays and compliance risks promptly.Supplier... ...patients first and make meaningful impact together.U.S. Pay Range$111,0...Full timeTemporary workRemote work
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