- Merck (Columbus, OH)
- **Job Description** The Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality ... SMEs. **Job Function:** + serve as a subject matter expert for good manufacturing practices ( GMP ) for...authority/board of health as an inspector, investigator, product reviewer, compliance officer, or other GMP /regulatory role +… more
- Kelly Services (Oklahoma City, OK)
- … GMP manufacturing processes for cell culture-based production, ensuring compliance with established protocols and regulatory guidelines. + Perform routine tasks ... + Detail-oriented and capable of maintaining accurate documentation in compliance with GMP standards. \#EX2BIO24 As part...hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical… more
- Kelly Services (Oklahoma City, OK)
- **Tech** **nical** **Writer ( GMP )** **Batch Record Review & Deviation Investigation** **Location** : Hybrid/Oklahoma City, OK **Job Summary** : We are seeking an ... experienced Manufacturing Tech Writer with a strong background in GMP environments and technical transfer. The ideal candidate will be responsible for creating,… more
- Kelly Services (Durham, NC)
- …to join our team. This critical role involves ensuring the cleanliness and compliance of cleanroom, controlled environment, and GMP laboratory settings. The ... ** GMP Technician** **Location: Durham NC** **Hourly Pay Rate:...hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Principal GMP Data Governance Specialist position. This role plays a pivotal part in ensuring that Regeneron's Data Governance ... and practices meet the highest standards of regulatory & industry compliance . The post-holder is responsible for providing specialized knowledge and expertise… more
- Mentor Technical Group (College Station, TX)
- …technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. ... and troubleshoot issues throughout the plant. + Take on SME (Subject Matter Expert ) roles for multiple facility and equipment systems and engage in continuous… more
- ManpowerGroup (Raleigh, NC)
- …training. Strong applied and working knowledge of FDA; GMP ; GLP; compliance and NIST traceability. Expert knowledge of test equipment and capabilities ... II is expected to have a broader knowledge base of instrumentation and regulatory compliance . They will continue to train on new instrumentation areas and build an… more
- Amgen (Holly Springs, NC)
- …support of inspections. In addition, the position may entail serving as a Subject Matter Expert (SME) for GMP compliance topics in support of various aspects ... career you can be proud of. **Senior Specialist Quality Compliance ** **Live!** **What you will do** Let's do this....vital role you will be part of the Regulatory Compliance function, the Senior Specialist of Inspection Lifecycle Management… more
- Schrodinger (Cambridge, MA)
- …appropriate oversight of all vendors, including CDMOs and CROs, to ensure regulatory compliance + GMP Responsibilities: + Serve as spokesperson and technical ... looking to hire a **Director, GxP Quality Assurance and Compliance ** to join us in our mission to discover...subject matter quality expert for all matters governed by GMP -related… more
- Boehringer Ingelheim (North Brunswick, NJ)
- **Description** + Be the "go to" technical expert for Global MSAT and Operations leadership for BIAH products and processes for analysis and guidance throughout ... MO or Duluth, GA.** **Duties & Responsibilities** + Be the "go to" technical expert for Global MSAT and Operations leadership for BIAH products and processes for… more
- Astellas Pharma (Sanford, NC)
- …the AGT Supplier Management program, internal audit program, inspection management and compliance oversight required to support GMP manufacturing operations at ... The primary purpose of the Senior Manager, Quality Assurance, Compliance is to provide Quality and Compliance ...AGT GMP operations as well as GMP suppliers. This role will be responsible for maintenance… more
- Colgate-Palmolive (Sanford, ME)
- …and requirements to CP personnel (local resident expert and leader for compliance and related GMP concerns).** + **Supervision and management of plant ... reason to smile and join our global team! **The Compliance Supervisor directs conformance to the GMP /Quality...**The Compliance Supervisor directs conformance to the GMP /Quality standards and establishes a culture to enable the… more
- Nestle (Phoenix, AZ)
- …charter. Manage data collection and feedback process for projects. Monitors processes for compliance with quality and GMP requirements in accordance with FDA and ... **TRAVEL:** 70 - 80% **POSITION SUMMARY:** The Engineering Project Manager Expert is responsible for providing technical leadership by identifying, developing and… more
- Astellas Pharma (Westborough, MA)
- …**Westborough, MA.** **Purpose:** This Compliance Specialist will perform critical QA compliance tasks in support of GMP manufacturing programs as AIRM moves ... ** Compliance Specialist** Do you want to be part...assistant auditor to help ensure all aspects of the GMP organization remain compliant with Astellas procedures and domestic… more
- Fresenius Medical Center (Lexington, MA)
- …(QMS) within the IT department. This position is responsible for ensuring compliance with established processes, documentation, and controls to drive efficiency and ... knowledge in GxP compliant documentation and quality management systems (ISO 9001, GMP , ISO 13485) as well as documenting computerized system validation and… more
- Lilly (Lebanon, IN)
- …Utilize sampling/testing equipment and supporting software and LIMS systems + Ensures compliance with current Good Manufacturing Practices ( GMP ) and maintain ... constant inspection-readiness + Ensures that data-integrity is maintained + Participate in process streamlining and continuous performance improvement Minimum Requirements: + Knowledge of / familiarity with pharmaceutical production environments and operations… more
- Astellas Pharma (Westborough, MA)
- …MA.** **Purpose:** This member of the Quality Assurance team will perform critical QA compliance tasks in support of GMP manufacturing programs as AIRM moves ... **QA Compliance Specialist** Do you want to be part...assistant auditor to help ensure all aspects of the GMP organization remain compliant with Astellas procedures and domestic… more
- Lilly (Indianapolis, IN)
- …+ Participate in projects as directed by GQAAC leadership that support or enhance GMP Compliance of larger quality organizations; ability to carry out mission ... Lead inspection readiness activities + Serve as a global compliance CGMP expert providing feedback in preparation...of current industry trends and regulatory agency interpretation of GMP and other relevant requirements + Continue to gain… more
- Bausch + Lomb (Greenville, SC)
- …within the global change management system (Kintana), and Data Integrity subject matter expert leading GMP data integrity program both for electronic and ... paper-based programs to ensure compliance with the global and regulatory requirements. This role...**Special Skills (preferred):** + Strong understanding of Pharmaceutical/Medical Device GMP , + GDP and QSR. This position may be… more
- Takeda Pharmaceuticals (Boston, MA)
- …and aligned with applicable regulations. You will report to and act as a strategic expert to the Head of GCP Quality Compliance in developing GCP Compliance ... reviews and approve outcome. + Be a Subject Matter Expert (SME) on the Clinical Quality Compliance ...guidance to other other non-GCP specific inspections (eg, GVP, GMP ). + Lead complex quality investigations improving the clinical… more