- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …SOP-s of QA/Production/Warehouse/QC/Validation/IT etc. Innovation: + Operate in compliance of cGMP , 21CFR, USP, EP and ICH regulatory requirements. KNOWLEDGE, SKILLS ... AND ABILITIES: Education : Bachelor of Pharmacy or relevant science degree Knowledge and Skill: 15-25 years in Pharmaceutical Industry - Investigations, Sterile Manufacturing Quality Assurance, Validation and Qualifications, Quality System and Compliance,… more
- Fujifilm (Holly Springs, NC)
- …of experience * Familiar with Raw Material methodology as it pertains to cGMP * Experience with LIMS software **Physical and Work Environment Requirements:** Ability ... to discern audible cues. Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. Ability to stand for prolonged periods of time up to 240 minutes Ability to sit for prolonged periods of time up to 240… more
- WestRock Company (Mebane, NC)
- …waste. Must complete all hourly checks and maintain quality consistent with cGMP practices and specifications. Must complete all production and process control ... documentation. Must relieve crew members for breaks, lunches and communicate with crew members to solve any problems that may arise quickly. What you need to succeed: * Must be able to complete make readies on all gluers efficiently and complete all key areas… more
- Fujifilm (Holly Springs, NC)
- …Change Control, Validation) * Provides guidance and quality oversight of cGMP activities supporting all material and product disposition including drug substance ... manufacturing, labeling, batch record review, and lot Disposition * Provides status reports and quality metrics to support management review process * Partners with cross-functional teams to ensure products are delivered on time and within specification *… more
- ThermoFisher Scientific (High Point, NC)
- …goals. + Maintains quality service by establishing and implementing organization and cGMP regulation standards + Ensures operation of equipment by placing work ... tickets for repairs and coordination with maintenance. + Provides manufacturing information by compiling, initiating, sorting, and analyzing production performance records and data + Builds and revises systems, batch paperwork, and procedures by analyzing… more
- Lilly (Durham, NC)
- …Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP 's, FDA 21 CFR Part 11) and other applicable regulations (eg privacy, ... OSHA, etc.). + Demonstrated ability to lead and influence cross-functional teams with a strong customer service focus. + Strong analytical and problem-solving skills. + Highly motivated and self-starter. **Additional Skills/Preferences** + Experience with… more
- WestRock Company (Conover, NC)
- …scissors. * Understands and respects responsibilities of working in an SOP and cGMP environment. * Performs other job duties as assigned. * Maintain housekeeping and ... 5S to standards set by management. Follow all WestRock Core Values and Behaviors. Additional job duties as assigned by department manager. * Diagnose and repair complex mechanical and electrical breakdowns as well as pneumatic, hydraulic and general building… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …and rAAV vectors at smaller scales. The GVVC will manufacture, under cGMP , rAAV vectors using industry standard manufacturing processes and analytical methods. The ... Director will perform the operations involved in the Manufacturing area to achieve the objectives of the Gene Therapy Center and its clients ensuring proper compliance with cGMPs to achieve strategic objectives, promote the growth of people and facilitate… more
- Kedplasma (Hickory, NC)
- …+ Reviews donor record files to ensure completeness, accuracy, and compliance with cGMP . + Maintains a clean, orderly, and efficient work environment and ensures ... sufficient operating supplies are available as needed. + Responsible for verifying and changing supply lot numbers when a new lot number is introduced into production. + Follows all SOPs and regulatory policies and procedures, including the employee handbook… more
- Kelly Services (Clayton, NC)
- …and oversight + Employee relations and staffing + Ensure compliance with cGMP regulations and department safety standards. + Provide expert guidance to manufacturing ... and regulatory departments on GxP-related matters. + Make informed, independent decisions within the defined scope of responsibility. + Plan, delegate, and prioritize tasks to meet project timelines and budgets. + Represent the department during internal and… more