- Pall (Miami, FL)
- …understanding of ISO 9001 and AS9100 / CAA Part 145/CAA Part 21 standards. GMP , FDA knowledge and other ISO standards an advantage.Good understanding of ... applicable regulatory requirements covering Food Contact, Product Compliance (Ce Marking, ATEX, ASME etc.), Product Environmental Compliance (ROHS/REACH) and airworthiness (CAA/FAA)The salary range for this role is 155,000 - 180,000. This is the range that we… more
- Cytiva (Miami, FL)
- …device production.2+ years experience with regulatory standards and quality systems (eg, FDA , ISO 13485, Good Manufacturing Practices - GMP ).2+ years experience ... and improve process performance ensuring compliance with regulatory requirements (eg, FDA , ISO, PSM) and contribute to audits and inspections as necessary.Who… more
- Beckman Coulter Diagnostics (Miami, FL)
- …including GMP and QSR requirements for medical devices. (ISO13485, FDA 's QSRs, EU's MDD, Canadian Regulations) is required. Proficiency in the Microsoft ... regulations and standards including compliance with Food & Drug Administration ( FDA ), Medical Device Single Audit Program (MDSAP), ISO13485, European Union Medical… more
- Butterball (Mount Olive, NC)
- …clean water lines.Coordinates all daily sanitation activities within the plant.Follows all GMP and HACCP procedures that relate to cleanliness and product safety ... maintain and promote a safe work environment.Read and understand HACCP along with FDA and OSHA requirements as needed.Education & Experience: High School Diploma or… more
- Butterball (Mount Olive, NC)
- …workplace for all.*Ensure product safety and product defense in the plant.*Follows all GMP and HACCP procedures that relate to cleanliness and product safety with ... maintain and promote a safe work environment.Read and understand HACCP along with FDA and OSHA requirements as neededProven ability to work in a fast-paced and… more
- Butterball (Mount Olive, NC)
- …clean water lines.*Coordinates all daily sanitation activities within the plant.*Follows all GMP and HACCP procedures that relate to cleanliness and product safety ... maintain and promote a safe work environment.*Read and understand HACCP along with FDA and OSHA requirements as needed*Proven ability to work in a fast-paced and… more
- Aldevron (Fargo, ND)
- …implementation of analytical test methods within the QC Laboratory for GMP testing of nucleic acids, proteins, and lipid nanoparticles (LNPs).Lead Deviation ... through publications or previous experience.Regulatory Knowledge: Strong understanding of FDA , EU, and ICH regulations related to test method validation,… more
- Aldevron (Miami, FL)
- …experience in a Quality with experience working in a regulated or GMP compliant environment and leading projects or related experience.Exposure to regulatory agency ... inspections or other types of audits (eg, FDA , notified bodies, ISO, etc.).Current or past Quality certifications a plus (eg ISO 9001, ASQ, etc.)Strong EQPreferred… more
- Aldevron (Fargo, ND)
- …the implementation of analytical test methods within the QC Laboratory for GMP testing of nucleic acids, proteins, and lipid nanoparticles (LNPs).Support deviation ... test method validation, test method transfer, and method development.Foundational knowledge of FDA , EU, and ICH regulations related to test method validation and… more
- Actalent (Holly Hill, FL)
- …OTC and cosmetic products. This hands-on leadership role ensures all processes comply with FDA 21 CFR Parts 210 and 211, GMP (Good Manufacturing Practices), and ... to employees, identify skill gaps, and recommend training opportunities. Compliance with FDA Regulations, GMP & SOPs + Ensure all activities align with FDA … more
- Teleflex (Chelmsford, MA)
- …and ensure compliance with all company policies, rules, procedures, and housekeeping / GMP / FDA standards. **Education / Experience Requirements** * Minimum of ... influence people and teams at all levels. * Knowledge of ISO 13485 / FDA / GMP regulations. * Must be fluent in English. * Demonstrated record of continuous… more
- Herbalife (Winston Salem, NC)
- …for this position. **Experience:** + A minimum of 2 years of experience in FDA or GMP regulated industry **Education:** + High-school diploma (or equivalent) ... + Assist production staff with the correct understanding and implementation of GMP procedures and company policy + Document and investigate (as appropriate) foreign… more
- Revlon (Oxford, NC)
- …leadership in a production environment. + Knowledge and experience with operations in a FDA - GMP environment + Significant communication skills - verbal and ... budget goals. + Coaches and trains associates to meet or exceed Quality, GMP , Safety and good Housekeeping Standards. + Must have proficient computer skills. *Backup… more
- Endo International (Rochester, MI)
- …in a body of information required for the job_ _e.g. knowledge of FDA regulations, GMP /GLP/GCP, Lean Manufacturing, Six-Sigma, etc._ + Possesses knowledge of ... that products are developed, manufactured, tested, and packaged according to applicable FDA guidelines, regulations, GXPs, and internal SOPs + Provides counsel on… more
- Herbalife (Winston Salem, NC)
- …paced environment. Experience: * A minimum of 5 years of Supervisory experience in FDA or GMP regulated industry * PCQI or HACCP Certification * Manufacturing ... required from an accredited institution or additional 2 years of experience FDA or GMP regulated industry in lieu of degree PREFERRED QUALIFICATIONS: * 4-year… more
- Abbott (San Diego, CA)
- …+ Minimum 7 years of Software Quality Engineering experience. + Detailed knowledge of FDA , GMP , IEEE 1012 and ISO 13485. + Advanced computer skills, including ... and geographically diverse business environment. + Detailed knowledge of FDA (including 21 CFR Part 11), GMP , IEC 62304, EN 61010, EN 60601, IVDR, ISO 19471,… more
- University of Colorado (Aurora, CO)
- …complete, and submit accreditation application documentation for appropriate regulatory agencies, including FDA ( GMP and GTP), ASHI, CAP, AABB, AATB, and FACT. ... on compliance with all standards. + Assess updates to FDA regulations on human cells, tissues, and cellular and...and understanding of federal regulations on biologics including GTP, GMP , BLA, and IND. + Knowledge and understanding of… more
- Fortive Corporation (Irvine, CA)
- …PQ validation** for facility, automation, and process systems. + Ensure compliance with ** FDA , EMA, GMP , OSHA, and safety regulations** . + Support **regulatory ... operations, engineering, automation systems, and process improvements** in a ** GMP -regulated manufacturing environment** . This role ensures **compliance, efficiency,… more
- Actalent (Allentown, PA)
- …creation, oversight, and approval. The ideal candidate must be familiar with ISO13485, FDA , and GMP regulations. Responsibilities + Manage and control quality ... Create, oversee, and approve labeling. + Ensure compliance with ISO13485, FDA , and GMP regulations. + Handle complaint management and resolution. + Participate… more
- Abbott (San Diego, CA)
- …and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA , GMP and all other applicable agency regulations + Anticipate and ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
