- Novo Nordisk Inc. (West Lebanon, IN)
- …specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch records, supporting test ... assist in the internal audit program and be a QA presence on the manufacturing floor. Essential...certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open… more
- Merck & Co. (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. Project ... Job DescriptionOur Quality Assurance group ensures all materials...PM EST. (May include weekends and holidays)Preferred Experience and Skills: GMP quality experience with biological drug substance… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal ... GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch...leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all… more
- Merck & Co. (Rahway, NJ)
- …with internal stakeholders and partners such as Chemical Engineering, Process Chemistry, Quality Assurance and pilot plant support staff.Support internal and ... Research and Development group has an opening for a Specialist based in Rahway, NJ. Join us and experience...analytical support for timely results.Support the execution of Good Manufacturing Practices ( GMP ) activities such solvent and… more
- Catalent (Manassas, VA)
- …work with complex formulations to help create engaging new products consumers will love.The Quality Assurance Specialist I - Quarantine is responsible for ... standards. Communicate any deviations to management. Assist the Quality Assurance team with special projects as...(Standard Operating Procedures and Test Methods) and Knowledge of GMP and quality systems For business and… more
- Catalent (Manassas, VA)
- … Quality System documentation. Communicate any deviations to management. Assist the Quality Assurance team with special projects as required. Comply with SQF, ... and follow documents (Standard Operating Procedures and Test Methods); Knowledge of GMP and Quality systems.Basic Microsoft Office (Excel, PowerPoint, and Word)… more
- Pacer Staffing (Elkton, VA)
- Title: Quality Specialist - I (Assistant) Location: Elkton, VA 22827 Duration: 8 months Shift Hours: Monday to Friday, Standard time. Summary: If you are the ... scientific field and a minimum of two (2) years' experience in Pharmaceutical, Manufacturing , Maintenance or Military environments or GMP . OR Master's degree… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …Quality Control, Analytical Development, Manufacturing and Quality Assurance to ensure compliance with GMP requirements. What You'll DoParticipates in ... External US About This Role The QC LIMS Sr. Specialist 1 is accountable for support of the Laboratory...reporting and resolution(s) to Quality Control laboratory, QA , AD and Manufacturing staff, as needed… more
- United Therapeutics (Eden Prairie, MN)
- …How you'll contribute The Senior QA Specialist - GMP Manufacturing , is responsible for supporting quality operations during GMP clinical ... manufacturing of bioengineered organs at Miromatrix. The Senior QA Specialist collaborates with and provides support...Certificates of Conformance + SOPs: Author, revise and approve Quality -related SOPs in eDMS. Own Change Controls + … more
- Seattle Children's (Seattle, WA)
- …biotechnological, or pharmaceutical industry hands on QA experience in a GMP biologics manufacturing environment. Required Credentials: + N/A. Preferred: + ... the Seattle Children's Therapeutics with development, implementation, and maintenance of quality assurance systems and activities. Perform internal audits,… more
- United Therapeutics (Eden Prairie, MN)
- …therapies to help patients with liver and kidney disease. How you'll contribute The Quality Assurance Specialist II ensures that all intermediates and ... the Miromatrix are manufactured in accordance with current Good Manufacturing Practices ( GMP ) and meet all internal...SOPs, Work Instructions (WIs), MBRs, Specifications and TMs + Quality Metrics: Support QA manufacturing … more
- Randstad US (Burlington, MA)
- quality assurance specialist - gmp . + burlington...include: + working in a smoke free environment Skills + QA /QC + QAQC + Quality Assurance ... a Specialist /Senior Specialist to support Quality On The Floor (OTF) oversight of manufacturing...appropriate escalation. + Identify risks and communicate gaps for quality and GMP process/systems. + Reviews and… more
- GE HealthCare (Boston, MA)
- **Job Description Summary** The Good Clinical Practice (GCP) Senior Quality Assurance ( QA ) Auditor is crucial in ensuring that clinical trials are conducted ... to R&D & GCP activities but also to the GMP manufacturing sites, GDP, PV, and GLP...of quality assurance processes. + Quality Metrics and Reporting: QA Auditors may… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Staff QA Specialist (Filling) position with our Drug Product Quality Assurance team. This position will support ... Quality Assurance initiatives for a broad range of topics relative...packaging/labeling and/or visual inspection for each level: + Principal QA Specialist - 8+ years + Staff… more
- Editas Medicine (Cambridge, MA)
- …cooperative, highly motivated and experienced quality professional to support internal GMP manufacturing operations. This position will be responsible for ... at the Editas Waltham and Devens GMP manufacturing facilities as a member of the Quality...the Editas Waltham and Editas Devens GMP manufacturing facilities. Key Responsibilities: As the Principal Specialist… more
- IFF (Newark, DE)
- …Family of Companies Requisition ID : 492478 Job Description IFF in Newark, DE is seeking a Quality Assurance Specialist to join our team! The Quality ... regulatory requirements and corporate quality standards. The Quality Assurance Specialist works closely...and Food Safety requirements. + Responsible for enforcing Good Manufacturing Practices and other quality -related policies to… more
- Merck (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. Project ... **Job Description** Our Quality Assurance group ensures all materials...include weekends and holidays)** **Preferred Experience and Skills:** + GMP quality experience with biological drug substance… more
- Bristol Myers Squibb (Bothell, WA)
- …patients, there's no better place than here at BMS with our Cell Therapy team. The Quality Assurance Specialist position plays a key role in supporting the ... cGMP quality operations for the Bothell Manufacturing Plant...a regulated cGMP environment. The primary focus of the QA Specialist role will be to support… more
- J&J Family of Companies (Raritan, NJ)
- …recruiting for a ** Quality Assurance Equipment/Computer System Validation Specialist II-CAR-T Manufacturing .** This position will be located in Raritan, ... Quality Assurance Equipment/Computer System Validation Specialist II...other applicable standards. + Ability to interact effectively with manufacturing , automation/IT, laboratory, QA , and Facilities groups.… more
- Catalent Pharma Solutions (Chelsea, MA)
- **We're hiring for a rotating night shift Quality Assurance Specialist I to provide QA support for cGMP manufacturing activities, at our facility in ... better, healthier lives. The ** Quality Assurance Specialist I** is responsible for supporting the QA oversight of a GMP manufacturing facility.… more
