- 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
- Eurofins (West Point, PA)
- …and as part of a team, self-motivation, adaptability, and a positive attitude + GMP large molecule method development, validation , and/or project management ... two (2) years of large molecule (vaccine or biologics) method development, validation , or project management +...of two (2) years of working knowledge of a GMP laboratory environment + Technical writing experience + Ability… 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
- Curia (Albany, NY)
- …the QA efforts within the Analytical department + Review and Approval of Validation documentation ( Method and Equipment) and procedures to increase efficiency ... Senior Quality Assurance Specialist (QA/QC) in Rensselaer, NY Build your future...+ Work independently to lead & provide direction for method transfers with minimal oversight from management + A… 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
- 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
- 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 ... 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
- Eurofins (Lancaster, PA)
- …across the entire network of Eurofins companies. The Quality Assurance Senior Specialist is responsible for ensuring quality of operations and data being produced ... to routine and non-routine duties. Essential Duties and Responsibilities: + Applies GMP /GLP in all areas of responsibility, as appropriate + Demonstrates and… more
- Eurofins (Lancaster, PA)
- …process and all functional areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality control. ... Testing (BPT) Group is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive CMC… more
- AbbVie (Cincinnati, OH)
- …Change Management, Lab Equipment/Instrument procurement, installation, calibration, validation /qualification, Training and QC Lab support activities (like ... with corporate and governmental regulations. Responsibilities: . Serve as compliance specialist for the QC lab including routine assessment of lab compliance,… more