- Cole-Parmer (Raleigh, NC)
- …skills and troubleshooting abilities + Adherence to quality systems with special regard to FDA , ISO 13485 and GMP / OSHA compliance + QC testing of ... components and finished products + Inventory management of materials and supplies + Focus on continual process improvement + Cleaning and maintenance of equipment + Guided experimental design and product testing assigned by supervisor + Preparation of… more
- US Tech Solutions (Wilson, NC)
- …regulatory requirements applicable to biologics and/or pharmaceuticals and ability to apply GMP regulations and other FDA and international guidelines to all ... and records management in respect of SOPs and other GMP regulated documents + Receive and log documents submitted...+ Pharma background, helpful + Must have knowledge of FDA / EMEA regulatory documentation **Education:** + Bachelor's degree… more
- Pilgrim's (Sanford, NC)
- …housekeeping audits. + Develops sanitation procedures according to Good Manufacturing Practice ( GMP ), USDA and FDA regulations for all sanitation tasks. + ... Maintains GMP provisions and monitors employee practices that relate to cleanliness, sanitation and pest control. + Conducts safety training to comply with OSHA regulations and company standards. + Develops and implements new methods, procedures and… more
- BioLife Plasma Services (Raleigh, NC)
- …tasks require prolonged glove wear **Preferred Qualifications** + Familiarity with SOPs, GDP, GMP , CLIA, and FDA regulations + Experience working in a regulated ... industry or high-compliance environment **We Offer Comprehensive Benefits from Day One** + Major medical, dental, and vision insurance and prescription coverage for eligible employees + A minimum of 15 vacation days and 10 company-paid holidays + Tuition… more
- Fujifilm (Holly Springs, NC)
- … Quality Assurance and/or similar role, required + 3+ years of experience in GMP operations in an FDA regulated facility **Preferred Requirements:** + Experience ... and working knowledge of ASTM E2500, Smartsheet, Trackwise, Veeva, SAP, and/or Kneatvalidation software + Previous biopharmaceuticals experience: + Cell culture, upstream processes, large scale recovery + Experience with startup projects or initiative +… more
- BioLife Plasma Services (Raleigh, NC)
- …**PREFERRED QUALIFICATIONS:** + Associates or Bachelor's Degree + Experience working with SOPs, GDP, GMP , CLIA, and the FDA + Experience working in a highly ... regulated or high-volume retail environment + Excellent interpersonal, organizational, technical, and leadership skills \#LI-Remote **BioLife Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in… more
- BioLife Plasma Services (Raleigh, NC)
- …tasks require prolonged glove wear **PREFERRED QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP , CLIA, and the FDA + Experience working in a highly ... regulated environment **We Offer Comprehensive Benefits from Day One** + Major medical, dental, and vision insurance and prescription coverage for eligible employees + A minimum of 15 vacation days and 10 company paid holidays + Tuition reimbursement +… more
- Cambrex High Point (Durham, NC)
- …+ Overseeing and coordinating the daily prioritization of the laboratory functions for GMP and or non- GMP projects, including scheduling of assigned staff and ... and (where required) development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity, and impurities by… more
- Fujifilm (Holly Springs, NC)
- …are manufactured and tested in strict compliance with Good Manufacturing Practices ( GMP ) regulations. You will maintain quality systems that align with CGMP, GDP, ... and process together with monitoring of Quality metrics for GMP Operations + Works with internal teams and clients...in cGMP manufacturing operations and/or Quality role in an FDA /EMA regulated facility. * Experience and working knowledge of… more
- Astellas Pharma (Sanford, NC)
- …assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, ... functions to instill a 'Quality Culture' by coaching in the application of GMP principles including the underlying rationale of those principles. + Author, review… more