- Actalent (Cleveland, OH)
- …Complete regulatory documentation, report Serious Adverse Events, and assist with FDA /sponsor requirements. + Serve as a liaison among investigators, research staff, ... and external study partners. + Conduct and document informed consent. + Perform nursing assessments, provide patient care, administer treatments/medications, and coordinate ongoing care. + Assist with specialized equipment and support discharge planning. +… more
- Kelly Services (Barceloneta, PR)
- …which include documentation of work procedures frequently audited by the FDA and other regulatory agencies. + Perform cross-contamination cleaning methods in ... areas that require microbial control. + Complete cGMP documentation of training or cleaning performed on paper and electronic devices. Prepare cleaning solutions based on cGMP-regulated mixing instructions. + Perform microbial control cleaning techniques on… more
- Abbott (Plymouth, MN)
- …chain solutions. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... and task assignments. + Able to build collaborative relationships with and influence a matrixed organization of R&D, NPI, Finance, PMO, Site SC, Manufacturing teams + Maintains positive and cooperative communications and collaboration with all levels of… more
- TestPros (MD)
- …and OSC Project Manager (PM). Document that the documents fully passes the HHS and FDA checklists. Notify the PM when a document requires the insertion of Alt text. ... Perform final document remediation within ten (10) business days after the PM has reviewed and returned the work product to the contractor for final remediation. The process for remediation shall include: 1) The first remediation work product. 2) Review and… more
- ManpowerGroup (Tucson, AZ)
- …5 years of experience in manufacturing within a food production or FDA /USDA facility. + Understanding of lean manufacturing and continuous improvement philosophies ... and principles. + Experience managing project quotes, budgeting, scheduling, and contractor management. + Strong interpersonal skills to effectively collaborate with internal teams, vendors, and external partners. **What's in it for me?** + Comprehensive… more
- UNC Health Care (Raleigh, NC)
- …safety reports, and other necessary documents. Accommodate sponsor and/or FDA audits as necessary. **Other Information** Other information: **Education ... Requirements:** * Associate degree required. Bachelor's degree is preferred. **Licensure/Certification Requirements:** **Professional Experience Requirements:** * Previous experience in clinical or laboratory research field preferred. **Knowledge/Skills/and… more
- Grifols Shared Services North America, Inc (Menasha, WI)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures. + Maintains and ensures proper sanitation and cleaning of equipment and work areas between donors. **Primary Requirements:**… more
- Bristol Myers Squibb (Devens, MA)
- …cGMP regulations and guidance. + Knowledge and proven experience in FDA , EMA, or other regulatory authority. + Demonstrated leadership, interpersonal, communication, ... and motivation skills. + Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process. + Must be action-oriented and customer-focused and skilled in… more
- Northwell Health (Manhasset, NY)
- …Drugs (INDs), New Drug Applications (NDAs) and Food and Drug Administration ( FDA ) information requests. + Directs regularly scheduled reporting to program executive ... leadership, sponsors, and program team; reviews quality assurance reports generated by the data management core and develops plans with sites for corrective actions, as needed. + Selects, develops, manages, and evaluates direct reports; oversees the… more
- Astrix Technology (Cerritos, CA)
- …or OTC product company.** + Direct experience participating in and leading ** FDA audits.** + Strong working knowledge of **21 CFR regulations.** + Hands-on ... experience with **MOCRA compliance.** + Experience supporting **NDA submissions** for OTC products, particularly sunscreens. _This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have… more
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