Hybrid GxP Audit & Inspection QA Associate
Alnylam Pharmaceuticals, Inc.
Alnylam Pharmaceuticals in Cambridge, MA is seeking a Quality Assurance Associate, GxP Audits & Inspection Excellence to support day-to-day operations of the audit and inspection management program. The role ensures accurate records, trackers, and systems for inspection readiness and audit transparency. Reporting to the Associate Director, GxP Audits & Inspection Excellence, you will provide operational and administrative support for supplier quality management, audit lifecycle, and #J-18808-Ljbffr Alnylam Pharmaceuticals, Inc.
- Quality Assurance Associate, GxP Audits & Inspection Excellence Cambridge, MA Overview The QA Associate, GxP Audits & Inspection Excellence, supports day-to-day operations... ...integrity within these operations. This is a hybrid position primarily based in Cambridge, MA. Key...Suggested
- ...Specialist in Waltham, MA, offering a hybrid schedule with 3-5 days onsite. The role... ...research operations, quality systems, audits, and inspection readiness in a fast-paced pharmaceutical... ...strong knowledge of FDA regulations and GxP. #J-18808-Ljbffr Advantage TechnicalSuggested
$81.15k - $101.96k
...Quality Assurance Specialist reports to the senior manager of QA and will play a key role in managing the product quality... ...together with supporting QA activities, such as supplier audits and authority inspections. The key responsibilities of the position include, but...SuggestedFlexible hoursShift workAfternoon shift$50 per hour
...Specialist Location: Waltham, MA Schedule: Hybrid, 3-5 days per week onsite Pay Rate:... ...operations, quality systems, audit activities, and inspection readiness in a fast-paced pharmaceutical... ...of FDA regulations, ICH guidelines, GxP requirements, and regulatory compliance...SuggestedFor contractorsWork at officeLocal areaImmediate start3 days per week$85.4k - $158.6k
Reporting:Associate Director, Quality AssuranceDescription... .... The Senior QA Specialist plays a critical... ...to maintain a robust, inspection-ready quality culture.Illustrative... ....Inspection and Audit ReadinessPrepare for and... ...Requirements/Skills:Position is a hybrid role with 4 days a week...Suggested- Orion Castings in New Hampshire is seeking a Quality Auditor to join our die-casting operations. You will conduct audits, inspect processes, review records, and verify adherence to work instructions and customer requirements, supporting containment and corrective actions...
$98.5k - $109.1k
...strong understanding of quality systems, auditing, regulatory requirements, deviations/CAPA,... ...Prepare for and participate in regulatory inspections, compliance audits and sponsor audits. Support quality programs associated with hematopoietic progenitor cells, therapeutic...$70k - $85k
...Monitoring Program for the Chelsea Facility, including water and other utilities samplingProvide basic support during compliance inspections conducted by external sources such as health authorities; Initiate discrepancies, including deviations and investigationsSupport...Work at officeShift work- ...Quality Specialist will provide QA support of manufacturing operations... ...in preparation for quality audits and participate in corporate audits and external inspections as needed. Communicates proactively... ...with Quality Systems and other GXP Operational areas. Education and...Work at office
- ...compliance and quality across production activities in a 100% onsite GMP facility. Responsibilities include real-time review of batch records, materials management support, environmental monitoring participation, and assistance during inspections. #J-18808-Ljbffr Catalent, Inc.
$156.6k - $234.8k
...Operational Quality Associate director provides... ...ensure appropriate GxP compliance and consistency... ...and GCP Biomarker audit scope/focus for... ...to proactive inspection readiness activities... ...filings.Conduct Research QA (RQA) review of non... ....Flex Designation:Hybrid-Eligible Or On-Site...Full timeSummer workRemote workFlexible hours2 days per week- ...involves quality oversight of external manufacturing and testing activities for clinical-stage products, requiring strong knowledge of GxP documentation and regulatory compliance. Ideal candidates possess a bachelor's degree in a scientific discipline and proficiency with...
$60k - $68k
...to detail Ability to apply standardized QA criteria consistently and objectively... ...Prior quality assurance, quality control, or audit experience preferred Ability to work with... ...of employment and also work the same hybrid schedule as all employees. ~ Employer matched...Temporary workWork at officeRemote workRelocationShift work$28 - $30 per hour
...other support functions to ensure consistent adherence to approved procedures and quality expectations.Support internal audits, client audits, and inspection readiness activities by providing documentation, explanations, and on-the-floor support as needed.Maintain current...Contract workTemporary workWork experience placementWork at officeMonday to FridayShift workDay shift$50 - $55 per hour
...This position will assist with QA activities at the firm to... ...from internal/external quality audits or other sources Manage employee... ...Quality Assurance Specialist - Hybrid Eligible Cambridge, MA $132,00... ...00.00-$155,000.00 2 weeks ago Associate Director/Director, Quality Assurance...Full timeContract workFor subcontractorCasual workShift work- ...the areas of quality evaluations, product audits and resolution of non-conforming... ...other departments, as well as Customers. • Inspects and evaluates materials, parts and/or complete... ...to work in the designated country associated with the position will be considered.***...
- ...submissions, source data verification, and supporting batch disposition and quality systems compliance. The role requires strong knowledge of GxP documentation, regulatory requirements, quality systems, and cross-functional collaboration, along with excellent communication and...Work at office
- ...Quality Control AssociateThe Quality Control Associate is responsible for testing seafood... ...The QC Associate will participate in the inspection and grading of Grade-A products, perform... ...supervisor or managerConducts internal audits of plant and paperwork in conjunction with...Full timeMonday to FridayWeekend work
- ...in ensuring compliance of clinical studies, vendor management, and inspection readiness according to approved procedures, global regulations and ICH, GxP requirements. Support the processing of audit reports, change controls, deviation, and audit plans Support CQA team...
- ...Quality Control AssociateThe Quality Control Associate is responsible for testing seafood products and materials used during the manufacturing... ...back to management.The QC Associate will participate in the inspection and grading of Grade-A products, perform microbial and...
$94k - $132k
...MA; Denver, CO or Farmington, CT offices on a hybrid schedule. Under limited supervision, performs various auditing and compliance functions to ensure departmental... ...needs as required. The expertise you bring ~ Associates or Bachelor’s degree or equivalent experience...Full timeWork at officeFlexible hours- Title: QA Sr. Specialist GMPRemote/Onsite: Cambridge, MA HybridPay - $60/hr. - $65/hr. on w2DutiesReview of event documentation such... ...Volume 4, Annex 13)Understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry practices.Demonstrated teamwork,...Work at office
$111k - $123k
...operational support for Prime Medicine’s GxP software, equipment, calibration, preventive... ...keep systems and equipment compliant and inspection-ready.The role also conducts risk-based... ...vendor questionnaires, certifications, audit materials, quality agreements, and other...Full timeTemporary workRemote work- ...manufacturer and engineering solutions supplier worldwide. Summary The Quality Auditor is responsible for conducting quality audits and inspections to ensure manufacturing processes, products, and documentation meet established company standards, customer requirements,...Worldwide
$65 - $75 per hour
...records, and partners with cross-functional teams to maintain a compliant and efficient facility environment. Key Responsibilities Provide QA oversight of facility and equipment preventive maintenance, calibration, and related control programs. Review and approve work orders...Contract work$20.52 per hour
...Technicians for their team in Manchester, New Hampshire . The Lead Lab Technician will follow all quality control procedures for inspecting incoming raw materials and testing of finished products. The successful candidate will be familiar with laboratory work, comfortable...Hourly payMonday to FridayShift workNight shiftWeekend workDay shift- ...The QA Specialist assures consistent quality of production by developing and enforcing good manufacturing practice systems; validating processes; and ensuring products meet establish quality standards. The QA Specialist will work directly with the manufacturing team to...For contractorsLocal area
- ...QA Specialist Perform the QA review/approval of analytical documentation: Analytical method validation protocols and reports for... ...and release/stability testing Analytical method procedures and associated change controls Method technical transfer protocols and reports...
- Vertex is seeking a GMP Operational Quality Senior Specialist in Boston to support quality assurance and regulatory compliance across investigations, CAPA, and change control. The role emphasizes root-cause analysis, product impact assessments, and collaboration with cross...
- Orion Castings is seeking a Quality Auditor to conduct audits and inspections across the die-casting operation. You will verify processes against work instructions, control plans, and customer requirements, and document findings for corrective actions. You will work with...
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