- Amgen (Holly Springs, NC)
- …environment + 3+ years of experience with regulated environments (ie cGMP , OSHA, EPA) + Managerial experience directly managing people and/or leadership ... experience leading teams + Experience working with ATO GMP F&E clients and systems (Bulk Manufacturing, Filling and Packaging, Supply Chain, Quality Labs, Small Molecule Manufacturing) + In-depth technical knowledge of GMP equipment and instrumentation +… more
- GRAIL (Durham, NC)
- …guide staff to support the area and operators' day to day following cGMP /GLP and Quality Management System (QMS) guidelines. + Lead root cause investigations, drive ... for resolutions, and follow those up with corrective and preventative actions for area of responsibility + Make time sensitive technical decisions. + Support CAPEX/OPEX planning + Participate, be a role model, and adhere to GRAIL's policies and guidelines. +… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …operations, overall compliance, oversee department budget, employee relations,etc.). + Follows cGMP and department safety practices. + Provides guidance as well as ... consults with manufacturing and internal regulatory departments on GXP matters. + Uses expertise and sound judgment to make independent decisions within defined areas of responsibility. + Plans and analyze work flow, delegate and prioritize, to ensure that… more
- Mentor Technical Group (NC)
- …user access levels, audit trails, backup, restore, etc. + Knowledge of cGMP , GXP, GAMP, and good documentation practices. + Advanced knowledge of pharmaceutical, ... manufacturing and laboratory systems. + Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry. + Strong written and verbal communication skills. + Excellent interpersonal skills with experience dealing with a… more
- Amgen (Holly Springs, NC)
- …+ Knowledge and experience working in a highly regulated function - cGMP . + Experience executing and documenting maintenance work orders in a computerized ... maintenance management system. + Ability to interpret electrical schematics and drawings. + Ability to work with minimum direction. + Ability to effectively communicate issues and status of tasks in a timely manner. + Ability to interact constructively with… more
- Amgen (Holly Springs, NC)
- …+ Knowledge and experience working in a highly regulated function - cGMP . + Experience executing and documenting maintenance work orders in a computerized ... maintenance management system. + Ability to interpret mechanical drawings. + Ability to work with minimum direction. + Ability to effectively communicate issues and status of tasks in a timely manner. + Ability to interact constructively with peers/teams.… more
- Catalent Pharma Solutions (Greenville, NC)
- …logbook entries are accurately documented and compliant with SOPs and FDA cGMP guidelines. + With minimal supervision, conduct setup, changeover, and manufacturing ... activities with adherence to SOPs and safety requirements. + Other duties as assigned. **The Candidate** + High school diploma or equivalent with at least 2 years of experience in pharmaceutical OSD manufacturing or + Associate degree with at least 1 year of… more
- ThermoFisher Scientific (High Point, NC)
- …day in the Life: + Follow quality standards in accordance with company policy, cGMP and FDA requirements. + Assist in the installation and maintenance of utilities ... systems and equipment components for electrical power distribution, instrumentation and controls, electrical machinery, responsible for knowledge of codes and standards. + Perform preventive and predictive maintenance. + Performs alternating or rotating shift… more
- Amgen (Holly Springs, NC)
- …effectively perform associated maintenance activities. + Knowledge and experience within a cGMP or other highly regulated environment. + Working knowledge of local ... and national building code requirements. + Experience executing and documenting maintenance work orders in a computerized maintenance management system. + Ability to interpret mechanical drawings. + Ability to work with minimum direction. + Ability to… more
- Fujifilm (Holly Springs, NC)
- …development and success of your team + Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date ... training,performinggembawalks, and having a safety and qualitymindset culture within your team + Supports manufacturing investigations and continuous improvement projects + Coordinates with other functional areas for additional activities requiring access to… more