- Eclaro (Sanford, ME)
- …Overview: The Plant Document Specialist is responsible for managing Document Control programs that ensure all documents related to the product quality ... Plant Document Specialist Job Number: 24-02785 Use...the cGMP compliance programs Manage site's electronic and paper document control systems designed to achieve cGMP… more
- Eclaro (Bothell, WA)
- Benchtop Support Specialist Job Number: 24-02953 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Benchtop Support ... Specialist for our client in Bothell, WA. ECLARO's client...global applications used within the manufacturing, quality, and quality control organizations. This position requires a passion for IT,… more
- Actalent (Miami, FL)
- Job Title: Document Control Specialist Job Description We are seeking a diligent and detail-oriented Document Control Specialist to facilitate ... and distribution of pharmaceutical products, including the development and maintenance of document control systems. Responsibilities + Review change orders and… more
- Catalent Pharma Solutions (Greendale, IN)
- ** Document Control Specialist ** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose ... help create engaging new products consumers will love. The ** Document Control Specialist ** is responsible...records and documentation. + Responsible for ensuring compliance to FDA and cGMP standards for Quality Control ,… more
- Integra LifeSciences (Plainsboro, NJ)
- …improve outcomes. **RESPONSIBILITIES** + Responsible for supporting the maintenance of the document control system during **2nd shift** . + Day-to-day management ... and document reconciliation + Seve as a document control reviewer for new and revised...level efficiencies + Drive continuous improvement + Maintains all ISO/ FDA standard operating procedures, work instructions, and forms. +… more
- Transylvania Vocational Services (Brevard, NC)
- …in management of customer external databases. ESSENTIAL REQUIREMENTS: . Working knowledge as a Document Control Specialist of the following: | Quality Manual ... (QMS) | SQF -Food Safety & Food Quality | Document Control Procedure | Calibration Procedure -...records for all the primary packaging components to ensure FDA compliance. . Head up the Glass & Hard… more
- PCI Pharma Services (Philadelphia, PA)
- …Philadelphia facility. This Quality Management System includes Documentation Control , Investigation and CAPA Management, Training, Internal/External Audits, Customer ... and is responsible for all the upkeep, maintenance and control of all QA related documents. Such documents include...skills. + Basic knowledge of Lean Six Sigma and FDA cGMP's preferred. + Experience in Pharmaceutical industry preferred.… more
- BeiGene (San Mateo, CA)
- **General Description:** The Quality Control Specialist , Medical Writing Quality Control , is responsible for coordinating and completing Quality Control ... conforms to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical regulatory documents… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …pertaining to shared/impacted processes. + Communicates with Training Department and Document Control to facilitate Center and Corporate training related ... hybrid role based out of our RTP, NC office.** **Summary:** Processes change control requests to ensure that process and documentation changes with the potential to… more
- MD Anderson Cancer Center (Houston, TX)
- …all times to ensure document accessibility and chain of custody. **Regulatory Document Control ** Prepares registration documents on behalf of the CRF, such ... receipt from operational area for short and long-term archival within controlled access facilities. Maintain GMP Document Management under a state of control at… more
- Eurofins (Louisville, KY)
- …and maintain high standards for product quality and safety. Key Responsibilities: 1. Document Control Management: + Oversee the lifecycle of all QMS ... revision, approval, and archiving on electronic QMS. + Manage and maintain document control processes, ensuring compliance with applicable standards such as… more
- Integra LifeSciences (Boston, MA)
- …of Integra Boston's Quality Management System under the direction of the Manager of Document Control and Training or Quality Site Leader. **ESSENTIAL DUTIES AND ... duty satisfactorily. Primary responsibilities are to support site change control and document control activities... Control , + Record Control , Change Control + Experience with FDA and/or Notified… more
- Boehringer Ingelheim (Athens, GA)
- …reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist , Validation manages all phases of higher level, more complex validation ... for assuring compliance of validated systems, process, equipment to current cGMP, FDA , EU, USDA, BIAH and BI corporate requirements. This includes, but is… more
- L'Oreal USA (North Little Rock, AR)
- …for the implementation of solutions and corrective actions (when applicable) + Document Control + Development and maintenance of documentation + Monthly ... for internal and external audits. GENERAL REQUIREMENTS + Maintain Quality documents and Document Control Room + Perform external and internal audits as directed… more
- Food and Drug Administration (College Park, MD)
- …manages HFP's Occupational Safety and Health Program in coordination with the FDA 's Employee Safety and Occupational Health program. The incumbent uses applied ... be hazardous to workers' health and recommends measures to eliminate or control those hazards; anticipates health hazards and recommends preventive measures. Drafts… more
- Envista Holdings Corporation (Pomona, CA)
- …to learn and utilize computer in standard business applications including electronic document control , word processing, spreadsheets and databases. + Must be ... requirements and corporate standards. This involves assuring quality standards ( FDA , ISO, CMDCAS, MDD, MDR, MDSAP and Canadian Medical...assigned, in addition to those identified below + Ensures FDA QSR (GMP), FDA OTC, ISO 13485,… more
- Catalent Pharma Solutions (Harmans, MD)
- …audits; perform periodic walk-through audits of Analytical Development and Quality Control laboratories; Support regulatory ( FDA , EMA) and client ... **Senior Specialist , QA Analytical** **Position Summary** Catalent, Inc. is...for patients annually. Catalent's Harmans/BWI, MD facility is a FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The… more
- Integra LifeSciences (Boston, MA)
- …incorporation of taught skills and techniques into employees work behavior. + Working with Document Control and platform leads to review document curriculums ... set new standards of care. The Senior Quality Compliance Specialist -Training will create and conduct training programs to...are mapped to the appropriate associate. + Working with Document Control Team, Quality, and Manufacturing Engineering… more
- Unither Pharmaceuticals (Rochester, NY)
- …control committee meetings, training, and coaching site employees on the change control process. In addition, the Quality Systems Specialist will support ... Quality Systems Specialist Who we are? We are a French...be responsible for the oversight of the site change control system which will include facilitation of the change… more
- Medtronic (Minneapolis, MN)
- …compassionate world. **A Day in the Life** The **Associate Regulatory Operations Specialist ** is part of the Cardiac Rhythm Management Integrated Operating Unit ... processes. Responsibilities include assisting in the preparation, publication, quality control and delivery of paper and electronic regulatory submissions as… more
