- Biomat USA, Inc. (Research Triangle Park, NC)
- …out of our RTP, NC Office.** Ensures current Good Manufacturing Practices ( cGMP ) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review ... and quality assurance/control documentation. + Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment… more
- Novo Nordisk (Bloomington, IN)
- …contact for key customers + Manages QA resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, ... and approval of deviation investigations and change controls pertaining to CGMP production and testing + Supports the establishment, preparation, and communication… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …(-DIO-) is responsible for ensuring the accuracy and reliability of cGMP data and data supporting regulatory submissions. Generally, this requires implementing, ... and implementation of software used for the generation of cGMP data + Conduct audits and gap assessments based...and implementation of software used for the generation of cGMP data + Assess training program and materials for… more
- Actalent (Tampa, FL)
- …responsible for overseeing all quality and regulatory functions within a cGMP -compliant manufacturing environment. This role ensures that products meet internal and ... + Oversee Quality Management Systems (QMS) and ensure compliance with FDA, cGMP , and industry standards. + Manage audits, inspections, and regulatory submissions. +… more
- Bristol Myers Squibb (Summit, NJ)
- …in a professional and timely manner. + Respond in accordance with cGMP policies and procedures. + Perform routine calibrations and controls troubleshooting. + ... paperwork, ie, Logbooks, Work Orders, Calibration Documentation in accordance with cGMP good documentation practices. + Use various testing devices and standards… more
- System One (Cranbury, NJ)
- …in the production of solid oral dosage forms in a cGMP -regulated pharmaceutical environment. This role involves equipment setup, in-process testing, documentation, ... Complete all batch-related documentation, logbooks, and records in accordance with cGMP standards. Equipment Setup & Maintenance + Assemble and disassemble… more
- Novo Nordisk (Bloomington, IN)
- …products and stability samples, while adhering to SOPs and working in a cGMP compliant environment. The position will analyze and interpret results in written and ... to Supervisor. Essential Functions + Independently executes and properly documents cGMP Quality Control testing + Independently operates basic and moderately complex… more
- Cambrex High Point (Longmont, CO)
- …written instructions from a batch record under Good Manufacturing Practice ( cGMP ) conditions. In addition, the Associate Scientist is responsible for maintaining ... will operate under and develop subject matter expertise in cGMP practices and Good Documentation practices (GDP) within the...and cleans production equipment per written procedures. + Maintains cGMP suites to be tour/audit ready and prepared for… more
- Endo International (Rochester, MI)
- …overall quality/integrity of pharmaceutical products manufactured and distributed based on cGMP regulations and industry standards. The Site Head of Quality will ... quality authority for the site, ensuring that all activities comply with cGMP , ICH, FDA, EMA, and other applicable regulatory standards. Lead the implementation… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance. In this role, a typical day might include the following: ... product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partners. * Performing reviews of… more