Senior Quality Systems Specialist I - GMP/ISO Compliance
$115k - $140kWerfen
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 have 8+ years in the medical device sector and a bachelor's degree in science or engineering. The position is predominantly onsite with some remote flexibility and offers a competitive salary range of $115K to $140K. #J-18808-Ljbffr Werfen
$115k - $140k
...dedication to innovation and quality. We’re passionate about... ...of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations... ...Essential Functions: The Senior Quality Systems Specialist I will be expected to...SeniorWork at officeRemote workWorldwideShift work$111k - $185k
Summary of role We are seeking a Quality Compliance Senior Specialist who will be responsible for... ...internal Quality System audits, leading the Compliance... ...and knowledge of cGMP, ICH, ISO 13485, ISO 14971, and other... ...pharmaceutical and/or medical device GMP compliance regulatory...SeniorLocal areaWorldwide3 days per week- Anika in Bedford, Massachusetts is looking for a Senior Quality Assurance Specialist to provide quality oversight across manufacturing and CMC development... ...or pharmaceutical field, with a strong knowledge of GMP regulations. This role involves reviewing GMP documentation...Senior
- ...Senior Aseptic Manufacturing Specialist The Senior Aseptic Manufacturing... ...within ISO 7 and ISO 5 cleanroom... ..., ISO 13408, EU GMP Annex 1, and internal... ...to ensure compliance with batch record... ...functionally with Quality Assurance,... ...CAPAs, and quality system investigations....SeniorShift work
- ...Lead Quality Systems Auditor Fresenius Medical Care (FMC) is a people... ...Honesty and Integrity, Quality and Compliance, Collaboration, No-Limits... ...g. ASQ-CQA, ASQ-CBA, RABQSA, ISO 9001:2015) or equivalent education... ...Manufacturing Practices (GMP) and relevant quality...SuggestedWork at officeLocal area
- Senior Quality Lab Specialist Bedford, MA Role Summary We are looking for a skilled... ...Specialist will ensure regulatory compliance, lead audits, and drive... ...of our Quality Management System. This position will be... ...Quality role supporting CLIA, ISO 15189, or GCLP Experience...Senior
- A global leader in diagnostics is seeking a Senior Quality Systems Specialist to maintain and improve Quality Management Systems. Located in Bedford, MA, the role focuses on compliance with FDA and ISO standards, involving CAPA, internal audits, and training programs. Candidates...Remote work
- Syner-G is looking for a Senior Process Engineer based in Bedford, Massachusetts. This... ...sector, focusing on lyophilization systems. You will be responsible for the design... ...operational readiness of these systems, ensuring compliance with GMP standards. The ideal candidate will...Senior
$82.01k - $113.3k
...Watertown, Massachusetts, is looking for a highly motivated Senior Laboratory Operations Associate to support high-throughput laboratory... ...chemicals. This role focuses on operational excellence and compliance in GMP, vivarium, and chemistry labs. The position offers a...Senior$82.01k - $113.3k
...leading biotechnology company is seeking a Senior Laboratory Operations Associate in... ...focusing on high-throughput chemistry and GMP. The ideal candidate will manage laboratory... ...handle high-hazard chemicals, and ensure compliance with safety protocols. The position offers...Senior- ...seeking a Facilities Technician III to support maintenance of GMP and non-GMP systems. The role involves troubleshooting, advanced maintenance, and possibly mentoring junior staff while ensuring compliance with safety regulations. Qualified candidates will have 5-10 years...SeniorRemote jobFlexible hours
$84k - $105k
...alternative application process. Senior Quality Assurance Specialist (CMC) Regular Full-Time Bedford,... ...supply chain activities, ensuring compliance with global regulatory requirements... ...as a subject matter expert in GMP quality systems, CMC quality oversight, and regulatory...SeniorFull timeContract workImmediate start- A leading engineering firm is seeking a Senior Environmental Compliance Specialist / Environmental Scientist to support environmental compliance programs... ...projects, developing procedures, and ensuring compliance with ISO 14001. This position requires travel up to 50% of the...Senior
- ...Senior Principal Systems Engineer At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned...SeniorLocal area
$20 - $26.92 per hour
...Health Information Management Quality Control Specialist When you join the... ...Management (HIM) regulatory compliance. 1. Follows HIM QC error... ...experience, utilizing computer systems. Skills, Knowledge &... ...factors, that may include seniority, education, training,...Hourly payWork at officeShift work$50k - $60k
...Quality Assurance Associate Discovery Life Sciences (Discovery... ...'s Quality Management System and ensuring compliance with regulatory requirements... ...Good Laboratory Practice, ISO 9001. A Day in the Life... ...and ensure compliance with GMP and ISO standards Participate...Monday to Friday- ...Manager/AD, Clinical Data Management & Systems Join Apex Systems as a strategic data leader... ...collaboration to deliver high‑quality insights that shape clinical development... ...Oversee EDC systems and ensure GCP/GCDMP compliance Collaborate with Biostats, Clinical Ops,...Senior
- ...support facility operations in Bedford, Massachusetts. This role involves advanced maintenance, troubleshooting, and compliance support in GMP and non-GMP systems. The ideal candidate will have 5-10 years of experience and strong technical skills across HVAC, electrical, and...Senior
- Title: Senior OT Cybersecurity & CRA Compliance Architect Location: Bedford, MA (Hybrid) - 3 Days/Week. Duration:... ...regulatory compliance initiatives in a GMP-regulated pharmaceutical environment... ...PLC (ControlLogix/CompactLogix) systems, Ignition SCADA , and compliance with...Senior3 days per week
$160k - $195k
...target muscle and the central nervous system (CNS) to address the root cause... ...Facebook. Role Summary: The Senior Manager, GMP QA Operations oversees quality activities associated with contract... ...organizations (CMOs) and ensures compliance with FDA and global GMP...SeniorFull timeContract workWork experience placementLocal areaFlexible hours- ...Overview Zifo North America seeks a Senior Scientific Business Systems Analyst to support strategic R&D initiatives... ...) and support remediation of compliance gaps. Project Execution & Delivery... ...ensuring delivery on scope, schedule, and quality. Perform project management...SeniorFull timeRelocation package
- Quality Specialist/Technical Writer page is loaded## Quality Specialist/Technical... ...programs to ensure quality system readiness for external and internal audits and compliance with industry regulations and... ...industry regulations (e.g., ISO, GMP) related to documentation*...Minimum wagePermanent employmentWork experience placementWork at officeLocal areaShift work
- ...Sr. Quality Assurance Specialist A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states... ...on behalf of company. Support of Commercial QA Compliance: Deviation Review and Trending, CAPA Review and Trending....Senior
$180k - $247.5k
Symbotic LLC is seeking a Principal Software Engineer to define and drive the technical direction of core systems. You will lead high-impact initiatives and align teams around a clear technical vision. The ideal candidate must have a minimum of 12 years of software engineering...Senior$82.01k - $113.3k
...seeking a highly motivated Senior Laboratory Operations... ..., vivarium, and GMP operations. This individual... ...digital asset management system. Manage relationship... ...purification materials in compliance with EHS protocols.... ...Experience working in ISO 5, 7, and 8 cleanroom environments...Senior$132.4k - $251.6k
...concepts into reality? Do you thrive in dynamic environments? The Systems Engineering & Test Capabilities team discipline is seeking a... ...Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era...SeniorFull timeTemporary workWork experience placementInterim roleWork at officeLocal areaRemote workFlexible hours$66.8k - $124k
...Senior QA Specialist, RLT Manufacturing Operations We are seeking... ...to join Mariana's Quality Assurance... ...Specialist for Radioligand GMP Manufacturing Operations... ...and released in full compliance with cGMP, radiation... ...batches. Quality Systems Management Lead...Senior- ...at . Description As the senior technical resource on the... ...program, hazardous waste compliance program, and PM quality standards. The role performs... ...diagnosis and repair of furnace systems, compressed air... ...manufacturing environment such as GMP, ISO, aerospace, or medical...SeniorFor contractorsLocal areaAll shiftsShift work
- ...Antenna Engineer, Integrated GPS/INS/Vision Sensor Engineer, and Senior Embedded Software Engineer. Candidates should possess relevant... ...and experience, including proficiency in antenna design, GPS systems, and embedded software development. The company offers competitive...Senior
- ...Model-Based Systems Engineer (MBSE) Engagements Subject Matter Expert (SME) The Model-Based Systems Engineer (MBSE) Engagements Subject Matter Expert (SME) will drive the implementation of Model-Based Systems Engineering (MBSE) solutions at Raytheon. You will collaborate...SeniorRelocation package
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