- Eurofins (Cambridge, MA)
- …adapt ELISA methods for GMP applicability, ensuring readiness for validation and transfer. + Assess method performance characteristics, including ... for routine use. Key Responsibilities: + Design, execute, and document analytical method validation protocols for ELISA-based potency assays and other analytical… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Sr. Specialist 2, Global QC Raw Materials GMP Support is responsible for supporting, leading, and participating in activities within ... **Job Description** **What You'll Do** * Creates, maintains, and improves GMP documents and processes in collaboration with stakeholders and QA *… more
- Fujifilm (College Station, TX)
- **Position Overview** The QA Specialist III, QA Validation , will be responsible for the review and approval of commissioning/qualification/ validation ... reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA Validation , will handle all...and new construction final qualification requirements of TOP's for GMP facilities. + Single Use and Process Validation… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- **Senior Cleaning Validation Specialist ** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... your most difficult development and manufacturing challenges The **Senior Cleaning Validation Specialist ** position involves creating cleaning cycle development… more
- Bausch + Lomb (Greenville, SC)
- …Other chemical analysis techniques (titrations, wet chemistry, UV/Vis, FTIR, ICP-MS) + Method validation and verification requirements + Equipment validation ... raw data used to support product and raw material release, validation /engineering studies, and equipment maintenance. Assist with or lead laboratory investigations,… more
- Amgen (Thousand Oaks, CA)
- …and transform the lives of patients while transforming your career. ** Specialist Manufacturing - New Product Introduction & Manufacturing Execution System** **What ... as well as design electronic batch records supporting these introductions. This " Specialist Manufacturing" role will serve as a New Product Introduction (NPI) Lead… more
- Endo International (Rochester, MI)
- … GMP documents such as change control related documents, batch records, method validation protocols and reports, stability protocols and reports, analytical ... live their best life. **Job Description Summary** The Quality Specialist , Analytical QA provides the required Quality & Compliance...method transfer protocols and reports, and validation … more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The QA Specialist , QC Compliance is responsible for partnering in the Quality oversight of the Quality Control area. The QA Specialist ... from project phase through operational readiness, and provides oversight of validation program execution for these processes. This role collaborates with other… more
- Fujifilm (Holly Springs, NC)
- …equivalent with 0 years' relevant experience * 1-3 years' experience in a GMP environment * Experience in Validation , cGMP manufacturing operations and/or ... **Position Overview** The QA Specialist , Drug Substance Manufacturing (DSM) is responsible for...of DSM project processes. This role provides oversight of validation program execution for these processes and systems to… more
- Eurofins (North Brunswick Township, NJ)
- …subcontractors. + Audits various reports prior to issuance (eg analysis reports, method validation reports, research and development reports (as needed), special ... biological substances and products. Job Summary: Under minimal supervision, the Quality Assurance Specialist III will ensure systems and processes are in a state of… more
- Kelly Services (Houston, TX)
- Quality Control Microbiology Specialist Kelly science & Clinical is seeking a Quality Control Microbiology Specialist to join our client's QC team. As the QC ... Microbiology Specialist you will play a leading role in microbiological...with regulatory standards, and contribute to process improvements and method validations. Key Responsibilities * Perform and evaluate microbiological… more
- Merck (West Point, PA)
- **Job Description** **Position Description:** The Specialist - Quality Control, within Laboratory Operations, under the broad direction from the Associate Director - ... alignment of test methods and equipment including support for analytical method transfers. + Support capital projects and coordinate equipment projects for… more
- Actalent (Parsippany, NJ)
- …+ Proficiency in flow cytometry and quality control. + Experience in laboratory method validation , qualification, and transfer activities. + Ability to perform ... Title: QC Specialist Job Description The QC Specialist is responsible for performing method qualification...+ Minimum of 2 years of experience in a GMP setting or in the biotechnology or pharmaceutical industry.… more
- Fujifilm (Holly Springs, NC)
- …equivalent with 0 years' relevant experience * 1-3 years' experience in a GMP environment * Experience in Validation , cGMP manufacturing operations and/or ... **Position Overview** The QA Specialist , Operations (Nights) is responsible for partnering in...facility **Preferred Requirements:** * 2+ years of experience in GMP Quality Assurance and/or similar role * Experience and… more
- Abeona (Cleveland, OH)
- …not limited to: Master Production Records, Quality Control test methods/forms, Method Qualification/ Validation records, etc. Authorization includes a review of ... JOB TITLE SPECIALIST I, QUALITY ASSURANCE - QUALITY OPERATIONS Department...disposition pending issues to management. + Review qualification / validation protocols and reports and ensure resolution of and… more
- Amgen (West Greenwich, RI)
- …Join us and transform the lives of patients while transforming your career. **QC Specialist ** **What you will do** Let's do this! Let's change the world! n this ... testing against purchase orders. In addition to the above tasks, the QC Specialist will perform the following: + Support and perform QC laboratory investigations and… more
- Eurofins (Lancaster, PA)
- …in Europe over the past 20 years. Employee Responsibilities: + Perform method development, feasibility, qualification and/or validation of methods in support ... for GMP compliance + Perform tests accurately + Troubleshoot method and instrumentation problems + Use office and instrumentation specific computer software… more
- Catalent Pharma Solutions (Harmans, MD)
- …to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs. + Other duties, as ... and other viral vector-based therapies and vaccines. **Position Overview:** The Specialist , QA Batch Disposition supports GMP documentation for master/working… more
- Catalent Pharma Solutions (Harmans, MD)
- …to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs. + Other duties as ... other viral vector-based therapies and vaccines. **Position Overview:** The Senior Specialist , QA Batch Disposition supports GMP documentation for master/working… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Sr. Specialist 2, QC Instrumentation manages routine operations, continuous improvement, and life-cycle management of the QC analytical ... in alignment with regulatory guidelines and company policies. The Sr. Specialist executes and monitors the performance of routine maintenance, performs periodic… more