- Cipla (Central Islip, NY)
- …regulatory requirements. Understanding of regulatory compliance, quality management systems and document control processes, and the ability to collaborate ... and approval of the following types of documents: SOP's GMP documents Change control documents Review of...administration of analytical and QC equipment. Ensuring the GMP status and the functionality of the laboratory equipment… more
- Fujifilm (Holly Springs, NC)
- …power outages, fire alarms, and adverse weather events Ensures compliance with GMP , Occupational Safety and Health Administration (OSHA), and other regulatory ... ensuring compliance with safety, regulatory, and Good Manufacturing Practices ( GMP ) standards. Additionally, this role also provides training, technical support,… more
- Astellas Pharma (Westborough, MA)
- …Execution: Lead/co-lead, participate and support internal audits across all GMP -regulated areas, including manufacturing processes/cleanrooms, quality control , ... high-quality products to patients. Essential Job Responsibilities: Audit program administration : Develop, implement, and maintain the annual self-inspection master… more
- Graphic Packaging International, LLC (Omaha, NE)
- …Conducting and publishing GMP audits, raising and managing non-conformances. Administration of Quality Document requested from Customers. Job Specifications: ... Conduct quality inspection rounds during the designated shifts - including BBQ & GMP Audits and highlights and corrects any major issues. Random sampling of finished… more
- Charles River Laboratories (Bethesda, MD)
- …of the Asst. Facility/Facility Manager. You will maintain, monitor and document environment, room logs/records, provide training, monitor compliance and adherence to ... in a timely manner and monitoring employee progress Participate in Quality Control monthly team review Job Qualifications The following are minimum requirements… more
- Charles River Laboratories (Boston, MA)
- …orders for animal medications (anesthetics, analgesics, antibiotics, etc.) and will document distribution of medications and provide guidance on recordkeeping. Work ... by delivering operational and cost efficiencies through the strategic insourcing of GMP , GLP and non-GLP research services from discovery through safety assessment.… more
- Lilly (Lebanon, IN)
- …technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process control ... and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant… more
- Coherent (Saxonburg, PA)
- …Engineering Change Orders (ECOs). Assist in the development and implementation of document control procedures and best practices. Prepare documentation packages ... ensure compliance with quality standards (eg, ISO 9001, AS9100, FDA/ GMP as applicable). Maintain and update electronic document...audits, regulatory inspections, and customer requests. Train staff in document control processes and use of … more
- Kelly Services (Jacksonville, FL)
- …+ Maintains Vital Records Listing. + Prepares submissions of SOPs for the document control process controlled through eDMS (QUMAS)(Agile), ensuring compliance to ... **Documentation Control Specialist - Jacksonville, FL** Kelly Outsourcing Consulting...Office products, Software as required + Expertise in company document management computerized system (QUMAS) administrative side… more
- Globus Medical, Inc. (Eagleville, PA)
- …is critical because life cannot wait. **Position Summary** **:** The Quality Control Inspector is responsible for performing inspections at various stages of ... but not limited to QA Operations. This individual works with other quality control inspectors and engineers to ensure products or assignments align with the… more
- Sanofi Group (Pearl River, NY)
- …and all non-batch controlled materials into warehouse storage locations. Responsible for document control as it concerns order generation for picking documents, ... in departmental SOPs. Additionally responsible for inter-plant delivery, inventory control , proper certifications for maintaining licensure for the operation of… more
- Genentech (Hillsboro, OR)
- …system and database log review and maintenance, specifically within manufacturing control systems. + System design and administration experience supporting ... pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The IT… more
- ThermoFisher Scientific (Swedesboro, NJ)
- …TSA personnel requesting shipping documents and TSA agent walkthroughs of the facility. + Document creation & control within electronic document system, to ... Administration ) compliance. + Extensive knowledge and application of GMP (Good Manufacturing Practices) within pharmaceutical quality systems. **Knowledge,… more
- Fujifilm (Holly Springs, NC)
- …power outages, fire alarms, and adverse weather events + Ensures compliance with GMP , Occupational Safety and Health Administration (OSHA), and other regulatory ... ensuring compliance with safety, regulatory, and Good Manufacturing Practices ( GMP ) standards. Additionally, this role also provides training, technical support,… more
- Emmi Roth (Monroe, WI)
- …data and ensure prompt delivery.System & Data Management* Utilize ERP systems and document control platforms to manage compliance records.* Ensure data accuracy ... platforms (eg, TraceGains, SupplyShift).* Familiarity with customer portal systems and document control tools.Knowledge & Compliance* Understanding of food… more
- Endo International (Rochester, MI)
- …authority_ _( capital, operating, etc.), P&L responsibility, etc._ + Span of Control : oversight of five (5) budgetary departments representing seven (7) operational ... 3) Sterile Filling; 4) Inspection & Packaging, and 5) Manufacturing Administration + Operating Budget ~$15M; Spend/signing authority at $25K Key Accountabilities… more
- Dairy Farmers of America (Richmond, IN)
- …continued registration to Safe Quality Food (SQF) standards. Provide support in administration of Standard Operating Procedures (SOP) and hold programs. **JOB DUTIES ... review findings . File and maintain batch production and control records . Inform management of food safety management...issues are found. Ensure that supervisors fully explain and document production deviations . Document and update… more
- Bausch + Lomb (Greenville, SC)
- …for processing all Greenville documents and for the oversight and management of the document control program. This position is the site administrator for the ... document management electronic system (D2-GDMS) and ensures content of...on global initiatives. This position will also routinely provide administrative support for External audits (FDA, ISO, Global, etc.)… more
- Astellas Pharma (Westborough, MA)
- …Execution: Lead/co-lead, participate and support internal audits across all GMP -regulated areas, including manufacturing processes/cleanrooms, quality control , ... products to patients. **Essential Job Responsibilities:** + Audit program administration : Develop, implement, and maintain the annual self-inspection master… more
- General Dynamics Information Technology (Fort Detrick, MD)
- …dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, ... consultation for regulatory compliance, clinical (GCP), non-clinical (GLP), manufacturing ( GMP ), data management, biostatistics, product technical, safety monitoring, and… more
