- Strata-G, LLC (TN)
- …share the results of our successes with the community. Strata-G is seeking an experienced cGMP Quality Specialist with the following: Summary: The Quality ... to please our customers and to exceed their expectations. Quality We maintain a culture of continuous improvement. Safety...including maintenance of a Drug Master File + Conduct cGMP training for the program + Build and develop… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Senior Current Good Manufacturing Practices ( cGMP ) Specialist - Nuclear Pharmacy Technician position is responsible for adherence to ... daily tasks **GROWTH/INNOVATION ESSENTIAL FUNCTIONS** + Participates with the Quality Assurance Manager and/or cGMP Core Director...Participates with the Quality Assurance Manager and/or cGMP Core Director in defining quality policies.… more
- University of Southern California (Los Angeles, CA)
- …(https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP -Process-Development- Specialist \_REQ20145450/apply) ... for internal/external users in the university's current Good Manufacturing Practices ( cGMP ) facility. The Process Development Specialist is responsible for… more
- Boehringer Ingelheim (Fremont, CA)
- …scheduling modifications to relieve constraints. + Creates alignment with all Quality cGMP compliance, process requirements, readiness, timeline, and revenue ... reflect Boehringer Ingelheim's high regard for our employees. The Principal/Sr Specialist / Specialist , Manufacturing Performance Excellence and Planning will be… more
- Cardinal Health (Tallahassee, FL)
- …Ensures the site manufactures products to meet the requirements of 21 CFR 212 ( cGMP ). + Handles and ensures quality of documentation (control, retention, and ... + Engages and collaborates with operations department to drive quality system and cGMP requirements. + Performs product release activities per cGMP… more
- Cardinal Health (Sharon Hill, PA)
- …Ensures the site manufactures products to meet the requirements of 21 CFR 212 ( CGMP ) + Handles and ensures quality of documentation (control, retention, and ... activities + Engages and collaborates with operations department to drive quality system and CGMP requirements + Performs product release activities per CGMP … more
- Stanford University (Stanford, CA)
- Manufacturing Specialist **School of Medicine, Stanford, California, United States** Research Post Date Aug 20, 2024 Requisition # 104298 The Laboratory for Cell & ... Medicine (LCGM) at Stanford University School of Medicine is seeking a Manufacturing Specialist for the process development and manufacturing team. The LCGM is a~20k… more
- ThermoFisher Scientific (Allentown, PA)
- …day knowing that what they do matters. Discover Impactful Work: The Operations, Clinical Quality Assurance Specialist II will support all Quality functions ... are powered by people with an exceptional commitment to quality , deeply instilled ethics of personal responsibility and unrivaled...both verbally and written. Candidate should have experience with cGMP regulations. **A day in the Life:** + Applies… more
- Cardinal Health (Roseville, MN)
- …Ensures the site manufactures products to meet the requirements of 21 CFR 212 ( CGMP ) + Handles and ensures quality of documentation (control, retention, and ... activities + Engages and collaborates with operations department to drive quality system and CGMP requirements + Performs product release activities per CGMP … more
- Merck (Durham, NC)
- …the bulk active ingredient, finished product, and laboratory testing for vaccines. The Specialist , Quality Control participates in a team of analysts in the ... development, assay validation, equipment validation, and GMP laboratory readiness. The Quality Operations Laboratory Specialist performs laboratory testing on a… more
- Bristol Myers Squibb (Summit, NJ)
- …no better place than here at BMS with our Cell Therapy team. The Senior Specialist Quality Risk Management CAR T is responsible for supporting the S-12 Cell ... Shift **Responsibilities:** + The primary responsibilities of the Senior Specialist , Quality Risk Management are to evaluate...in science required. + Minimum 2 years' experience of Quality Risk Management in a cGMP /FDA regulated… more
- Kelly Services (Louisville, CO)
- **Sr. Quality Assurance Specialist - Louisville, CO** **Type:** Contract (6 months - potential for extension/conversion) **Shift:** M-F 8a-5p **Pay Rate:** ... $46-$55/hr **Position Summary** We are seeking a Contract Quality Assurance (QA) Sr. Specialist to support deviation investigations related to Good Manufacturing… more
- Merck (Durham, NC)
- …Manufacturing Practice and regulatory compliance during product manufacturing: + Direct in-line Quality support for all cGMP compliance, batch review, and ... product disposition. + Influence and Decision Making: + Represents Quality on the shop floor to influence cGMP... Quality on the shop floor to influence cGMP compliance and ensure product quality . +… more
- Hovione (East Windsor, NJ)
- …for the assigned projects and / or products in accordance with applicable cGMP , quality operational standards / procedures and legal regulations, ensuring the ... ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is… more
- ThermoFisher Scientific (San Francisco, CA)
- …modified cell processing for a variety of unmet medical needs. The QA Specialist II will provide Quality oversight for projects, performs compliance assessments, ... Fisher Scientific's broad portfolio of solutions and clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development… more
- WuXi AppTec (Philadelphia, PA)
- **Overview** The Quality Assurance Specialist - Testing reviews laboratory testing data/records in accordance with current Good Manufacturing Practices ( cGMP ... processes for adherence to established procedures/regulatory compliance. Provides guidance for quality related issues and consults with QA Management to resolve… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Senior Quality Compliance Specialist , Quality Assurance position on the Quality Assurance Change Control Team. This ... operational activities regarding partner change notifications. As a Senior Quality Compliance Specialist , Quality Assurance,...be for you if: * Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP , FDA regulations… more
- Cambridge Isotope Laboratories, Inc. (Xenia, OH)
- …degree requirement. + Minimum of 8 years of experience in a cGMP Quality , regulatory, and/or chemical manufacturing environment, with increasing responsibilities ... Separations (CIS) has an outstanding opportunity for an experienced Quality Assurance Senior Specialist based onsite in...member to uphold compliance and maintenance of the Company's cGMP (Current Good Manufacturing Practices) and Quality … more
- Eurofins (Columbia, MO)
- …a process driven regulatory compliant environment. Eurofins BPT-Columbia is looking for a Quality Engineering Validation Specialist to join our Quality ... Systems team located in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation...the Part 11 Team, QA, the validation teams, and Quality Engineering to assure compliance with US FDA regulations,… more
- WuXi AppTec (Philadelphia, PA)
- **Overview** In an inter-departmental team environment, works tofacilitate/incorporate effective quality practices for new and existing clients. Acts asthe Primary ... Quality Assurance Representative for designated clients. Review andapproval of...manufacturing batch records in accordance with current GoodManufacturing Practices ( cGMP ), and Good Laboratory Practices (GLP) forNonclinical Laboratory Studies,… more