- United Therapeutics (Research Triangle Park, NC)
- …control systems on automated pharmaceutical packaging equipment + Experience with GMP documentation requirements and have experience with completing batch packaging ... records, reading and understanding SOPs, and working with packaging machinery **Job Location** United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location 100% of the time. At United Therapeutics, our mission and vision are… more
- Controlled Contamination Services LLC (Durham, NC)
- …ensures the proper cleaning of the cleanroom, controlled environment and GMP laboratory environments. SCHEDULE: Part Time- Monday- Friday 5:00am-8:00am ESSENTIAL ... DUTIES AND RESPONSIBILITIES: + Perform cleaning operations under strict guidelines. Continually monitor the cleanroom cleaning procedures to ensuring all cleanings are completed promptly and correctly. + Responsible for participating in continuous training:… more
- Mentor Technical Group (Durham, NC)
- …maintenance to minimize downtime. + Ensure HVAC systems comply with GMP , safety standards, and industry regulations. + Troubleshoot system malfunctions and ... recommend solutions for efficiency and reliability. + Maintain accurate documentation of inspections, maintenance, and repairs. + Collaborate with cross-functional teams to support production and facility needs. Qualifications + EPA Certification (Universal… more
- Pfizer (Sanford, NC)
- …Standard Operating Procedures, batch records, compound records, forms and other related GMP documents. + Assist in maintaining control of documentation to include ... accurate document history and change revision documentation. + Coordinate the issuance, tracking, and review of batch records and other controlled documents to ensure target product-based cycle times are met. + Support the reconciliation and changeover of… more
- Mentor Technical Group (Durham, NC)
- …Knowledge of mechanical, electrical, and instrumentation systems. + Familiarity with GMP compliance, safety protocols, and documentation requirements. + Ability to ... troubleshoot and resolve equipment issues effectively. + Strong teamwork, communication, and problem-solving skills. Preferred Skills + Experience with reliability-centered maintenance (RCM) methodologies. + Familiarity with Computerized Maintenance Management… more
- Kelly Services (Durham, NC)
- …routine and investigational testing, environmental monitoring, data review, and implementation of GMP -compliant lab support systems. This role is hands-on in the lab ... and requires strong technical and operational knowledge of microbiological methods. **Key Responsibilities:** + Perform cGMP microbial testing, including endotoxin, bioburden, and environmental monitoring + Review raw data, perform peer or technical reviews,… more
- Mentor Technical Group (Durham, NC)
- …food manufacturing). + Strong knowledge of NEC codes, safety regulations, and GMP compliance. + Ability to read and interpret blueprints, schematics, and technical ... manuals. + Strong troubleshooting and problem-solving skills. + Excellent communication and teamwork abilities. Preferred Skills + Experience with automated systems, PLCs, and instrumentation. + Knowledge of cleanroom and controlled environment requirements. +… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + Ability to rapidly ... learn new procedures and reduce them to practice. + Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer. #biojobs more
- Astellas Pharma (Sanford, NC)
- …of gap remediation implementation. **Preferred Qualifications** + Experience in a GMP facility startup, high growth, and fast-paced environment + Experience working ... with Quality systems in a commercial-ready gene therapy facility. + Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies + Ability to proactively predict and resolve complex problems, think… more
- ThermoFisher Scientific (Greenville, NC)
- …lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, ... perfume, exposed piercings, facial hair etc allowed, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat,… more