- Willing to to work 100% on-site in Norwood, MA
- 2-4 years of experience in quality oversight or manufacturing experience in early stage clinical products
- Experience executing the review of batch records & GMP manufacturing experience
- Will be conducting Batch Record reviews both paper & electronic for QA
- Quality Systems experience (SAP & Veeva) is a plus
- Degree Required (BS or MS)
- Conduct thorough review of Master Batch Records (MBR) and electronic Batch Records (eBR), collaborating closely with the manufacturing team to ensure timely finalization of documentation.
- Perform quality inspections of logbooks that are pending review to ensure compliance and completeness.
- Provide quality supervision during the implementation of corrective actions and preventive actions (CAPA) and verify the effectiveness of these actions to sustain production continuity or advance processes to subsequent phases.
- Oversee the resolution of quality documentation, including deviations, change controls, CAPAs, Process Improvements (PI), and Engineering Changes (EC), prioritizing collaboration with interdisciplinary teams to expedite the completion of these records, addressing them in order of receipt or as per the backlog.
- Review and certify scanned copies of GMP documents submitted for archive.
- Additional duties as may be assigned as needed
- 2-4 years of experience in a GMP Manufacturing environment
- Bachelor's degree in a science related field
- A desire to make an impact as part of a high-growth, transformational company
-
Quality Assurance Coordinator
3 weeks ago
MES Solutions, Inc. Norwood, United StatesOverview: · Are you a Medical Scribe who prides yourself on your strong writing/grammar abilities? Are you also looking to step away from a medical office and into a work-from-home position? · If you answered yes, then this might be the job for you because **MES **is looking for ...
-
Specialist, Quality Assurance
3 days ago
Moderna Norwood, United States**The Role**: · The Quality Assurance Specialist is part of a cohesive team responsible for supporting cGMP oversight of internal manufacturing at Moderna Inc. · **Here's What You'll Do**: · Provides on-the-floor Quality support to Manufacturing. Makes quality decisions and/or es ...
-
Quality Assurance
1 week ago
Global Pharma Woburn, United States**Title: Quality Assurance** · **Location: Woburn, MA** · **Duration: 09 Months** · Client is a profitable technology company headquartered in Woburn, Massachusetts, USA. Client has developed a proprietary and patented Adaptive Focused AcousticsTM (AFA) technology platform which ...
-
Quality Assurance Employee in Production"
3 weeks ago
Quantum Innovations North Walpole, United States**About Bott GmbH & Co.KG: ** · At our company, you can make a big impact and confidently look towards the future. In our 90 years of history, we have evolved from a small manufacturing business to a full-service provider for vehicle and facility equipment. · What do we offer? · ...
-
Quality Assurance
1 week ago
EKS Solutions Providence, United States**Benefits**: · - 401(k) · - Bonus based on performance · - Competitive salary · - Opportunity for advancement · - Training & development · We are seeking a meticulous and detail-oriented individual to join our team as a Quality Assurance Food GMP Specialist. In this role, you wi ...
-
Quality Assurance Program Manager
1 week ago
INTEGRA TESTING SERVICES Needham, United StatesThe Quality Manager is responsible for leading the Quality Program for all CE Services locations and managing the onsite Microbiology Laboratory. · The Quality Manager assumes overall responsibility in ensuring that the division maintains operational and quality systems in a stat ...
-
Quality Assurance Technician
3 weeks ago
Ultra Electronics Braintree, United StatesUnleash the Power of Multi-Mission Excellence: Safeguarding the Seas for the World's Navies. · Step into a world where cutting-edge technology meets unparalleled expertise. Ultra Maritime pioneers delivering multi-mission solutions that protect and empower the naval forces worldw ...
-
Quality Assurance Specialist
3 weeks ago
DPS Group Boston, United StatesADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk assessments and obt ...
-
Quality Assurance Specialist
3 weeks ago
DPS Group TSO Boston, United States**Summary** · ADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk asses ...
-
Quality Assurance Inspector
3 weeks ago
Element2 Group Providence, United States**We are hiring for 3rd shift Quality Inspectors - 10:45pm - 7:15am** · - **MUST**_ have experience performing quality inspections and using measuring tool such as micrometers, calipers etc., · Available to interview immediately · **Overview**: · We are seeking a detail-oriented ...
-
Quality Assurance Specialist
2 weeks ago
Element Materials Technology Acton, United StatesOverview: · Element Materials Technology Boston-Acton, Inc. is looking for a full-time **Quality Assurance Specialist** to support the Quality Assurance Unit in a cGMP Microbiology Laboratory · **Responsibilities**: · - Comply with current Good Manufacturing Practice regulations, ...
-
Quality Assurance Inspector
3 weeks ago
Element2 Group East Providence, United States**We are hiring for 3rd shift Quality Inspectors for our manufacturing facility** · **Shift - 11pm - 7:30am** · **Pay - $20-$21/hr depending on experience.** · **Available to interview and start ASAP** · **Responsibilities**: · - Perform inspections on incoming materials, in-proc ...
-
Quality Assurance Manager
3 weeks ago
DV Die Cutting Inc. Danvers, United States**Overview**: · **Duties**: · - Develop and implement quality assurance policies and procedures · - Maintain ISO documentation · - Conduct regular quality audits to identify areas for improvement · - Oversee quality control processes, including QA/QC inspections · - Collaborate w ...
-
Specialist, Quality Assurance
1 week ago
Randstad North America, Inc. Norwood, United StatesAs the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a la Quality Assurance, Specialist ...
-
specialist, quality assurance
3 weeks ago
Randstad US norwood, United Statesspecialist, quality assurance. · + norwood , massachusetts · + posted 3 days ago · **job details** · summary · + $40 - $50.97 per hour · + contract · + bachelor degree · + category life, physical, and social science occupations · + reference48033 · job details · job summary: · As ...
-
specialist, quality assurance
3 weeks ago
Randstad US norwood, United Statesspecialist, quality assurance. · + norwood , massachusetts · + posted 1 day ago · **job details** · summary · + $40 - $50.97 per hour · + contract · + bachelor degree · + category life, physical, and social science occupations · + reference48033 · job details · job summary: · As ...
-
specialist, quality assurance
3 weeks ago
Randstad US norwood, United Statesspecialist, quality assurance. · + norwood , massachusetts · + posted 2 days ago · **job details** · summary · + $40 - $50.97 per hour · + contract · + bachelor degree · + category life, physical, and social science occupations · + reference48033 · job details · job summary: · As ...
-
specialist, quality assurance
1 week ago
Randstad US norwood, United Statesspecialist, quality assurance. · + norwood , massachusetts · + posted 3 days ago · **job details** · summary · + $40 - $50.97 per hour · + contract · + bachelor degree · + category life, physical, and social science occupations · + reference48123 · job details · job summary: · As ...
-
specialist, quality assurance
3 weeks ago
Randstad US norwood, United Statesspecialist, quality assurance. · + norwood , massachusetts · + posted 1 day ago · **job details** · summary · + $40 - $50.97 per hour · + contract · + bachelor degree · + category life, physical, and social science occupations · + reference48067 · job details · job summary: · As ...
-
specialist, quality assurance
1 week ago
Randstad US norwood, United Statesspecialist, quality assurance. · + norwood , massachusetts · + posted 5 days ago · **job details** · summary · + $40 - $50.97 per hour · + contract · + bachelor degree · + category life, physical, and social science occupations · + reference48067 · job details · job summary: · As ...
Specialist, Quality Assurance - Norwood, United States - Randstad Life Sciences US
Description
Specialist, Quality Assurance
6 Month Initial Contract
Norwood, MA | Onsite
Max PR: $50 per hour
Immediate Need for an Internal Quality Assurance Specialist in Norwood Massachusetts
MUST HAVE's
SUMMARY
The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced internally. He/she will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in early stage clinical products. They will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical and Process Development Technology Transfer counterparts.
RESPONSIBILITIES
Education & Qualifications
