Senior Quality Systems Specialist - GMP, CAPA & eQMS
Egenesisbio
eGenesis, a Cambridge, MA biopharma company, is seeking a Senior Quality Systems Specialist to support QA systems across GMP manufacturing and testing. The role reports to the Associate Director of Quality Systems and requires cross-functional collaboration within the organization. The position is based in Cambridge, MA. Key responsibilities include developing QA oversight processes, managing deviations and CAPAs, administering ELN, and advancing training and quality metrics. #J-18808-Ljbffr Egenesisbio
- ...POSITION SUMMARY The Senior Quality Systems Specialist will be supporting the QA team... ...Quality Systems supporting GMP Manufacturing and Testing... ...and manage deviations and CAPAs ensuring timely closure across... ...Management Systems (eQMS) is a plus PREFERRED QUALIFICATIONS...Senior
- ...access, and additive manufacturing. ABCorp is seeking a Senior Quality Systems Specialist to help strengthen and standardize our quality operating... ...practical dashboards and reporting for recurring quality issues, CAPA aging, audit findings, scrap/rework themes, and related...SeniorWorldwide
$55 - $60 per hour
...from JMD Technologies Inc. Title GMP Operational Quality Senior Specialist Employment Type Contract (6+ months... ...review Deviations, investigations, CAPAs, OOS/OOT management Quality on the... ..., Oracle, or similar QA/ERP systems Master’s degree with 2-3 years relevant...SeniorHourly payContract work$65 - $70 per hour
...Description The operational Area Senior Quality Specialist will provide QA support of... ...testing and other quality systems documentation as needed in... ...investigations ensuring appropriate CAPA actions are identified... ...QA support and oversight of GMP manufacturing operation Pay...SeniorContract workImmediate startMonday to Friday- ...Description Job Description Manufacturing & Quality Systems Gap Assessment Consultant Location:... ...controls, as well as regulatory and GMP requirements associated with hormone... ...for corrective and preventive actions (CAPAs). Key Responsibilities Conduct a systematic...Suggested
- eGenesis, a Cambridge-based biotech company, is hiring a Senior Quality Systems Specialist to bolster QA across GMP manufacturing and testing. The role reports to the... ...drive quality processes, manage deviations and CAPAs, oversee documentation and training programs, and...Senior
- ...Summary: The Operational Area Senior Quality Specialist will provide QA support of... ...testing and other quality systems documentation as needed in... ...QA support and oversight of GMP manufacturing operation... ...investigations, Root Cause Analysis and CAPA Experience with network...SeniorWork at office
- Vertex Pharmaceuticals in Boston seeks a Quality Systems Senior Specialist to design and deliver metrics across GxP operations and provide actionable insights to quality leadership for trends and deviations. The role supports packaging/labeling validations, manufacturing...Senior
- ...response times, high-quality matches, and virtually... ...: Operational Area Senior Quality Specialist Location : Boston,... ...Description The GMP Operational Quality Senior... ...Director of Quality Systems. Key... ...Ensures appropriate CAPA actions are identified...SeniorContract workTemporary work
- Anika in Bedford, MA is seeking a Senior Quality Assurance Specialist to provide QA oversight across CMC... ...serve as a subject matter expert in GMP quality systems, regulatory readiness, and... ...ready programs, manage deviations and CAPAs, and maintain high-quality documentation...Senior
- ...FDA-regulated industry. The position requires significant experience in operations and maintenance, along with knowledge of GMP and CMMS systems. Candidates should be adept at managing work orders, calibrations, and deviations while ensuring compliance with safety standards...Senior
- A leading firm in IT Services and Consulting is seeking a GMP Operational Quality Senior Specialist in Boston, MA. The role includes providing quality oversight and operational support for GMP manufacturing, requiring a strong background in QA operations and experience...Senior
- WHOOP is seeking a Quality Systems Specialist I to lead and improve the QMS for SaMD and digital health products. You will own quality processes, manage eQMS, and drive CAPAs, audits, and continuous improvement to ensure regulatory compliance and product quality. This role...Work at office
$105k - $135k
...daily lives. WHOOP is looking for a Quality Systems Specialist I to be a core member of the Digital Health... .... Administer and maintain the eQMS, including document control, post-market... ...processes including complaint management, CAPA and nonconformances, training, change...Full timeWork at officeRelocation$66.8k - $124k
...seeking an experienced Senior QA Specialist, RLT Manufacturing... ...Operations to join Mariana’s Quality Assurance organization... ...for Radioligand GMP Manufacturing Operations... ...manages deviations and CAPAs, and partners closely... ...radioligand batches. Quality Systems Management Lead or...Senior$122k - $150k
Kailera Therapeutics is seeking an experienced professional to manage GMP documentation and ensure compliance within their Boston facility. The ideal candidate will have over 6 years in the FDA regulated pharmaceutical industry, demonstrating strong skills in documentation...SeniorFlexible hours$55 - $65 per hour
Job Description The Quality Systems Senior Specialist supports design and delivery of impactful metrics and analyses across GxP operations. The incumbent... ...to batch release. Reviews and approves investigations, CAPAs, and change controls for external programs. Support day...SeniorContract workTemporary workWork experience placement- ...headquartered in Bedford, MA, seeks a Senior QA Associate to provide QA... ...’ll ensure QC activities meet GMP/GLP standards and regulatory... ...release, change controls, CAPA, and collaboration with multiple... ...departments to sustain product quality and safety throughout the...Senior
- ABCorp is seeking a Senior Quality Systems Specialist to enhance quality practices during a transformative period. This high-impact role focuses on the Quality Management System and aims to improve execution and process consistency. The ideal candidate will have over 5...Senior
- ...Pharmaceuticals in Boston is seeking an Operational Area Senior Quality Specialist to provide QA support for manufacturing,... ...role where you will lead investigations, CAPA actions, and drive continuous improvement in quality systems and batch release processes. #J-18808-...SeniorMonday to Friday
$111k - $185k
...Summary of role The Supplier Quality Senior Specialist is responsible for... ...SQM) program, ensuring that systems, processes and procedures between... ...supplier-related deviations and CAPAs relating to non-conforming... ...7+ years’ experience in a GMP environment, preferably in a...SeniorContract workFor contractorsLocal areaRemote work- ...of technicians and contractors. You will ensure reliable operation of regulated medical device facility systems, manage CMMS, and drive maintenance strategies in a GMP environment. The role requires 8-10+ years of facilities maintenance, a MA Wastewater License, and...SeniorFor contractors
- ...materials and consumables for internal manufactured products. Reviews GMP documentation for incoming raw materials and consumables for... ...retrievable. Assists department with weekly/monthly/quarterly Quality System data review metrics and reporting pertaining to materials...Senior
$70.49k - $113.52k
...enhance our collective expertise Senior Quality Engineer Responsibilities:Quality Oversight & GMP Operations Provide Quality... ..., facility, and computer system qualification documentation... ...Corrective and Preventive Actions (CAPA) Ensure investigations are scientifically...SeniorTemporary workWork experience placement- ...can imagine.The Work:The Senior SAP PM & QM Consultant... ...Plant Maintenance and Quality Management processes within... ...process harmonization, system design, and go-live... ...corrective/preventive actions (CAPA), Stability Studies -... ...with ISO 9001, GMP, FDA 21 CFR Part 11, or...SeniorFull timeWork experience placementLive inWork at officeLocal areaShift work
$122k - $150k
...Review and approve Service Provider GMP documentation Review and approve master... ...I‑III clinical programs Review GMP Quality Events, change controls, CAPA’s, and other GMP documentation as... ...effectively Compile data for Quality System Reviews Evaluate GMP activities for...SeniorLocal areaFlexible hours3 days per week- What You’ll DoThe Senior Quality Assurance Specialist provides quality assurance oversight across CMC development... ...as a subject matter expert in GMP quality systems, CMC quality oversight, and... ...effectiveness monitoring of deviations, CAPAs, and change controls.• Identify...SeniorFull timeContract workImmediate start
$60 - $65 per hour
Overview Role: Validation & Quality Assurance Consultant (GMP) Location: Boston, MA (Onsite - Monday to Friday... ...through effective quality systems and risk-based decision-making. Key... ...investigations, root cause analysis, and CAPA implementation. Review and manage change...Hourly payContract workMonday to Friday- Quality Compliance & CAPA Training Specialist Quality Compliance & CAPA Training Specialist 2 days ago Be among the... ...from Grove Technical Resources, INC Senior Recruiting Manager @ Grove Technical... ...Leadership, Recruitment Job Title: GMP CAPA & Training Specialist-...Contract work
$77.25k - $119.48k
A leading pharmaceutical company in Watertown is seeking a Quality Control Analyst. Responsibilities include laboratory maintenance, preparation... ...have a BS/BA in Chemistry/Biochemistry and 3-8 years of GMP experience. The role offers a competitive salary range from $77,...Senior
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