GMP Compliance & Quality Investigations Specialist

Stark Pharma Solutions Inc

Stark Pharma Solutions Inc. in Massachusetts seeks a Technical Compliance Associate to support GMP manufacturing and Quality activities in a regulated environment, focusing on investigations, deviations, NCRs, CAPAs, change controls, and batch documentation. You will partner with Manufacturing, Quality, and Engineering to resolve compliance issues on the floor and support audits, with a strong emphasis on documentation and GMP procedures. #J-18808-Ljbffr Stark Pharma Solutions Inc

Apply

Vacancy posted 3 days ago

Similar jobs that could be interesting for youBased on the GMP Compliance & Quality Investigations Specialist in Burlington, MA vacancy

Quality Assurance Specialist
$81.15k - $101.96k
...Quality Assurance Specialist About PharmaEssentia: It's not often you get the... ...Supply Chain Security Act) compliance together with supporting QA... ...control, deviations, investigations, corrective and preventive... ...guidelines, and relevant GCP, GMP, and GDP expectations....
Suggested
Flexible hours
Shift work
Afternoon shift
3 days per week
PharmaEssentia Corporation
Burlington, MA
2 days ago
QA Compliance Specialist
$66k - $82k
...What You’ll Do As the QA Compliance Specialist , you’ll help ensure Anika... ...operations meet applicable quality, regulatory, and documentation... ...and complete, support investigations and corrective actions, and... ...experience and familiarity with GMP and ISO requirements are...
Suggested
Full time
Internship
Work at office
Immediate start
Anika Therapeutics
Bedford, MA
1 day ago
Quality Specialist, CQA
...-50/hr *depending on expThe Clinical Quality Specialist, under the direction of the CQA management... ...and their operations in ensuring compliance of clinical studies, vendor... ...Support CQA team in the coordination, investigation, escalation, and resolution of issues...
Suggested
Planet Pharma
Waltham, MA
10 hours ago
Quality Control Analyst II
...Quality Control Technical Operations Analyst II The Quality Control... ...standards of quality and compliance from development through to commercialization... ...in data trending, investigations, and laboratory operations.... ...industry standards (e.g., GMP, GLP, ICH guidelines) to maintain...
Suggested
Shift work
LanceSoft
Cambridge, MA
1 day ago
HIM Quality Control Specialist
$20 - $26.92 per hour
...Information Management, the Health Information Management Quality Control Specialist provides continuous quality review of electronic medical record... ...and Health Information Management (HIM) regulatory compliance. Job Description Follows HIM QC error monitoring procedures...
Suggested
Hourly pay
Work at office
Shift work
Beth Israel Lahey Health
Burlington, MA
1 day ago
Clinical Quality Specialist
$50 per hour
Now Hiring: Clinical Quality Specialist Location: Waltham, MA Schedule: Hybrid, 3-5 days... ...in clinical quality and regulatory compliance? We're seeking a Clinical Quality Specialist... ...documentation Coordinate quality investigations, issue resolution, and corrective...
For contractors
Work at office
Local area
Immediate start
3 days per week
Advantage Technical
Waltham, MA
5 days ago
Senior Quality Specialist
...1797 Summary: The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations... ...providing QA support and oversight of GMP manufacturing operation Experience successfully leading event investigations, Root Cause Analysis and CAPA Experience...
Work at office
Katalyst Healthcares & Life Sciences
Somerville, MA
1 day ago
Quality Assurance / Operations Analyst
$90k
...Aspen Publishing is seeking a Quality Assurance/Operations Analyst to be a part... ...eStore (Shopify) administration, including investigating customer and configuration issues... ...accessibility considerations and WCAG compliance a plus Familiarity with UX Design &...
Full time
Work experience placement
Work at office
Work from home
Night shift
Aspen Publishing
Burlington, MA
15 days ago
Senior Quality Systems Specialist
$110k - $120k
...precision, reliability, and quality matter every time. Because engineering... ...As a Senior Quality Systems Specialist at Lexington Medical, you... ...the CAPA system, ensuring investigations, root-cause analysis, and... ...product quality and QMS compliance on track as processes and products...
Lexington Medical, Inc.
Bedford, MA
4 days ago
Quality Analyst
$82.3k - $220k
...Job Description Summary: The Quality Analyst at Draper provides support for... ...role in maintaining standards, ensuring compliance and supporting quality teams. The incumbent... ...quality and/or property audits. Identify, investigate, and resolve issues Interface with...
Full time
Contract work
Local area
Flexible hours
Draper Labs
Cambridge, MA
1 day ago
Warehouse Operations & Quality Compliance Specialist
Lancesoft in Bedford, MA is seeking a Warehouse Processes Specialist for a 12-month assignment. You will execute inbound goods receipt,... ...storage, and outbound picking, packing and shipping with a focus on quality and patient safety, updating WMS and ERP transactions...
Lancesoft
Bedford, MA
22 hours ago
Sr. QA Specialist (Fri-Sun 6am-6:30pm)
$100k - $115k
...process development, produce GMP viral vectors, and provide... ...operations, the Senior Quality Assurance Specialist champions collaborative day... ...and provide regulatory compliance guidance during on-the-floor... ...inspections. Assist in deviation investigations, CAPA and Change Control...
Live in
Visa sponsorship
Shift work
Genezen
Lexington, MA
a month ago
CMC QA Associate
...) to confirm the appropriate quality as well as compliant controls... ...at external partners Ensure GMP processes are implemented in... ...leading and participating in investigations into manufacturing and analytical... ...%). Expert knowledge of cGMP compliance regulations and industry...
Contract work
Local area
The Steely Group
Bedford, MA
10 hours ago
Sr. Quality Assurance Specialist
Sr. Quality Assurance SpecialistA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri... ...manufacturing on behalf of company.• Support of Commercial QA Compliance: Deviation Review and Trending, CAPA Review and Trending.•...
Careers Integrated Resources Inc
Lexington, MA
3 days ago
QA Specialist, Biopharma — Impactful Quality & Compliance
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...
PharmaEssentia U.S.A.
Burlington, MA
3 days ago
Quality Systems Consultant
...greater Boston area is looking to add a Quality Systems Consultant to its team for the next... ...and eDMS/eQMS administration * Strong GMP and data integrity backgroundQualifications... ...pharmaceutical quality assurance and GxP regulatory compliance experience supporting GxP document...
Planet Pharma
Burlington, MA
10 hours ago
Chief Quality & Regulatory Officer
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...
LightForce Orthodontics, Inc.
Wilmington, MA
2 days ago
QC Lab Analyst - Radiopharma Testing & Compliance
Lantheus Medical Imaging Inc in Massachusetts is seeking a QC Laboratory professional to perform routine and advanced testing on incoming materials, reference standards, solutions, finished product release and stability in a cGMP environment. This is an onsite role based...
Lantheus Medical Imaging Inc
Billerica, MA
2 days ago
Quality Control Analyst II
...under cGMP conditions, ensuring product quality, regulatory compliance, and timely release of materials. In... ..., participate in laboratory investigations, and support implementation and closure... ...industries. Demonstrated knowledge of GMP and ISO regulatory requirements....
Full time
Immediate start
Anika Therapeutics, Inc.
Bedford, MA
2 days ago
QC Analyst - Microbiology (Temporary, 2nd shift, Sat-Mon, 12pm-12:30am)
$30 - $45 per hour
...process development, produce GMP viral vectors, and provide cell... .... The role also supports quality management systems, including... ..., non-conformance, deviation investigations, corrective and preventive actions... ..., are performed in compliance with all industry regulations...
Hourly pay
Contract work
Temporary work
For contractors
Live in
Visa sponsorship
Night shift
Afternoon shift
Genezen
Lexington, MA
22 days ago
Quality Control Specialist
$88.43k - $125k
...Wilmington, MA Methuen, MA 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 Engineering, Operations, Sales, internal teams, suppliers, and customers, to help ensure...
Permanent employment
Full time
Work at office
Visa sponsorship
Work visa
Relocation package
MKS Instruments
Wilmington, MA
5 days ago
Senior Quality Systems Specialist
$107.1k - $138.6k
...Senior Quality Systems Specialist eGenesis is a clinical-stage biotechnology company developing human... ...and manage Quality Systems supporting GMP Manufacturing and Testing across all... ...Implement process improvements to enhance compliance and improve method and product quality...
eGenesis Bio
Cambridge, MA
5 days ago
QC Physical Testing Analyst
$72k - $107k
...solving skills to support & possibly lead investigations. Participate in protocols for procedural... .... Work individually and as a team with quality and attention to detail. Good... ...in the pharmaceutical industry, related GMP environment, or equivalent highly preferred...
Work experience placement
Casual work
Weekend work
Afternoon shift
Lantheus Medical Imaging Inc
Billerica, MA
2 days ago
Quality Assurance Specialist III
Job DescriptionDescriptionThe Quality Assurance Professional will work in the US External... ...biologics products. Interfacing CMO for site compliance documentation, quality systems review (... ...data, and deliverables. Experience with GMP programs in cGMP biotech and/or pharmaceutical...
Contract work
Flexible hours
LanceSoft
Lexington, MA
4 days ago
Senior Quality Assurance Specialist
$85.4k - $158.6k
Reporting:Associate Director, Quality AssuranceDescription:... ...Quality Assurance Specialist, to join Mariana’s... ...and released in full compliance with cGMP, radiation safety... ...radiopharmaceutical GMP requirements, aseptic... ...quality events, including investigations related to deviations,...
Mariana Oncology
Watertown, MA
10 hours ago
Quality Control / Documentation Analyst
...responsibility is the testing and release of raw materials for GMP use in manufacturing. In this role, the primary... ...the specific project, document writing/revising to ensure compliance with regulations and quality control practices. The person in this role may also be asked...
Katalyst Healthcares & Life Sciences
Lexington, MA
4 days ago
QC IT Application Analyst
Job-ID33176208Reference26-01909 Key Responsibilities: GMP / GxP Operations: Support Quality Control IT operations, computer system validation (CSV)... ...diagrams) adhering to 21 CFR Part 11 and Data Integrity compliance. Lab Instrument Support: Provide technical oversight and...
Katalyst Healthcares & Life Sciences
Lexington, MA
2 hours ago
Quality Control Associate
..., support and recruiting services to various government and Fortune 500 clients. Job Description *Must have experience working at a GMP facility (bio-tech or pharma regulated industry)* Job Details: Under general supervision, this position will perform routine procedures...
Work experience placement
Internship
Rangam Consultants Inc
Woburn, MA
10 hours ago
Senior Quality Engineering Specialist
$111k - $123k
...a diversified portfolio of investigational therapeutic programs organized... ..., please visit .Department: Quality AssuranceReports to: VP,... ...Senior Quality Engineering Specialist provides hands-on operational... ...providers, escalating delays and compliance risks promptly.Supplier...
Full time
Temporary work
Remote work
Prime Medicine
Cambridge, MA
3 days ago
Quality Assurance Specialist - GCP/GLP
...We are seeking an experienced Quality Assurance Specialist to help establish and maintain an... ...quality systems, ensuring regulatory compliance, maintaining data integrity, and supporting... ...records. Review deviations, investigations, CAPA effectiveness, and quality-...
For subcontractor
MEDICILON USA CORP
Lexington, MA
1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to GMP Compliance & Quality Investigations Specialist. Be the first to apply!