- Actalent (St. Louis, MO)
- …inspections. Skills: Quality assurance, Annual product review, label, change control, Gmp , Fda , quality systems management, pharmaceutical, Audit Top ... Description: Quality Assurance Specialist - Quality Systems, supports all quality system elements to assure compliance with FDA cGMP and other quality… more
- FFP (Eustis, FL)
- …skills + Working knowledge, skills, and ability to understand and maintain compliance to all FDA , HACCP, GMP 's, and quality control systems + Ownership of ... is produced on-time and meets or exceeds the company's quality standards and that all work is performed in...team-based and hands-on work environment + Strong safety and quality awareness + Team building, employee development, and leadership… more
- FFP (Eustis, FL)
- …skills + Working knowledge, skills, and ability to understand and maintain compliance to all FDA , HACCP, GMP 's, and quality control systems + Ownership of ... for ensuring all product is produced on-time and meets or exceeds the company's quality standards and that all work is performed in a safe and efficiently manner… more
- Mayo Clinic (Jacksonville, FL)
- …and inclusion, and provides the resources you need to succeed. **Responsibilities** The Sr. Quality Analyst, FDA Regulated Manufacturing will be part of a team ... related field is preferred or a bachelor's degree, 5 years' experience supporting FDA regulated product manufacturing, and 5 years quality , regulatory, or… more
- BioFire Diagnostics, LLC. (Lombard, IL)
- …Minimum of 1 year of experience in training development, ideally in an FDA -regulated setting. + Instructional design or GMP -related certifications are preferred. ... all shifts. This role focuses on maintaining compliance with FDA , ISO 13485, ISO 9001, ISO 14001, and ISO...with LMS platforms, particularly ComplianceWire. + Strong understanding of GMP , Good Documentation Practices, and quality systems… more
- Medtronic (Northridge, CA)
- …designs by navigating c- GMP (current Good Manufacturing Practices), 21CFR820, FDA quality assurance requirements for design and manufacturing and packaging; ... of the following: Medical Product or Packaging engineering compliant to c- GMP , 21CFR820, FDA quality assurance requirements, and EU-MDR; authoring test… more
- Mentor Technical Group (Juncos, PR)
- …(MTG) provides a comprehensive portfolio of technical support and solutions for the FDA regulated industry. As a world leader in life science engineering and ... Puerto Rico, Dominican Republic, Mexico, Germany, Canada and South America. The GMP Cleaning and Sanitization Group Leader will assist the Supervisor in ensuring… more
- Adecco US, Inc. (Mansfield, MA)
- …(1) years experience in manufacturing operations with medical devices. * Knowledge and experience with GMP , ISO, FDA , and quality standards * Experience in a ... as required by clients. Adherence to Good Manufacturing Practices ( GMP ) and FDA , ISO, and environmental requirements....as required by the company - Production accuracy and quality - Accurately follow manufacturing procedures and quality… more
- Kelly Services (Oklahoma City, OK)
- …from scratch. + Review, revise, and maintain technical documents to ensure they meet current GMP , regulatory, and quality standards. + Act as the lead writer for ... projects. + Familiarity with deviation and CAPA processes. + Strong understanding of GMP regulations ( FDA , EU, etc.). + Excellent writing, editing, and… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …health authorities (eg FDA , EMA, MHRA, etc.) + Excel in a quality driven organization + Have an understanding of biologics manufacturing operations To be ... We are currently looking to fill a Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive activities that… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Staff GMP Data Governance Specialist plays a pivotal part in ensuring that Regeneron's Data Governance systems and practices meet the highest standards of ... with regulatory requirements and industry standards. As a Staff GMP Data Governance Specialist, a typical day might include...plan. Lead DI remediation activities as per the DI Quality Plan + Work in partnership with other Technical… more
- System One (Allentown, PA)
- Title: Quality Inspector ( GMP ) Location: Allentown Pa Type: 6-10 month contract Shift: Monday- Friday 6AM - 2:30PM Pay: $20/hr Start: Immediate Responsibilities: ... experience in pharmaceutical inspection or related fields. + Knowledge of FDA cGMP regulations. + Familiarity with Quality Control/Assurance principles.… more
- Novo Nordisk (Clayton, NC)
- …+ Minimum of three (3) years progressively responsible experience in material management &/or GMP quality , required + Experience in one or more of the following ... At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For...+ API & raw materials a plus + Regulations GMP &/or ISO a plus + Pharmaceutical or other… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Staff GMP Data Governance Business Partner role implements the data governance standards, policies, and procedures into business operations. This position serves ... (IOPS) Data Governance and Integrity program. As a Staff GMP Data Governance Business Partner, a typical day might...of these within IOPS. + Fostering a culture of quality & DG within the organisation. + Promoting the… more
- Regeneron Pharmaceuticals (Troy, NY)
- …and the following amount of experience in one of the following pharmaceutical/ FDA regulated work areas: data management, quality assurance, compliance, ... We are currently looking to fill a Director of GMP Data Governance position. This position acts as a...unit(s). It plays an integral part in safeguarding the quality and reliability of the organization's data which is… more
- Regeneron Pharmaceuticals (Troy, NY)
- …monitoring DG practices. The role is pivotal in promoting data stewardship, improving data quality and ensuring DG principles are embedded in the site culture. As a ... Senior GMP Data Governance & Engagement Specialist, a typical day...of these within IOPS + Fostering a culture of quality & DG within the organisation and promoting the… more
- Randstad US (North Billerica, MA)
- …raw materials and finished goods while maintaining product/lot segregation in compliance with FDA and cGMP guidelines. Skills + GMP + Material Handling ... gmp material handler. + north billerica , massachusetts...Supports several groups such as Manufacturing, Supply Chain Operations, Quality and other site customers providing Materials Handling needs… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …and the following amount of experience in one of the following pharmaceutical/ FDA regulated work areas: data management, quality assurance, compliance, ... The Director, GMP Data Governance role is fundamental in ensuring...mergers, acquisitions, and partnerships + Fostering a culture of quality & DG within the organisation and promoting the… more
- ThermoFisher Scientific (Middleton, WI)
- …Shift (Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Office, Some degree of PPE (Personal Protective ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Sr/Executive Director, GMP Data Governance & Integrity position. This position is responsible for the Regeneron Industrial ... of one or more of the following pharmaceutical or biotech areas: Manufacturing, Quality Control, Quality Assurance, or Information Technology + Are knowledgeable… more