- Merck & Co. (Durham, NC)
- …and/or microbiological laboratory proceduresProvide active support during audits and inspections ( regulatory , internal , safety)Assist regulatory groups by ... Notification authoring and provide audit support. GENERAL PROFILE: Collaborate with internal customers and vendors to identify, evaluate, and implement new… more
- Merck & Co. (Rahway, NJ)
- …transfer to internal and external manufacturing sites, manufacturing investigations , process validation, and authoring of regulatory submissions. -Under ... direction of Director in the CCFS group and working in conjunction with internal and external partners, this individual will support late stage and commercial large… more
- Merck & Co. (Durham, NC)
- …meet established delivery timelinesProvide active support during audits and inspections ( regulatory , internal , safety)Assist regulatory groups by providing ... Lean Laboratories, and GMP requirements.- GENERAL PROFILE: Work cross-functionally with internal sites and global partners to build and operate testing capability… more
- Merck & Co. (North Wales, PA)
- …transfer to internal and external manufacturing sites, manufacturing investigations , process validation, and authoring of regulatory submissions. - ... direction of Director in the CCFS group and working in conjunction with internal and external partners, this person will support late stage and commercial large… more
- Merck & Co. (Durham, NC)
- …aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external ... cGMP-compliant state and represent the laboratory during audits and inspections ( regulatory , internal , safety)Build and maintain strong relationships with site… more
- Merck & Co. (Rahway, NJ)
- …of GMP Operations, will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, ... Operations team.Ensure inspection readiness and offer prompt support during regulatory , quality, and safety inspections.Address audit findings and identify trends… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QMS, PV/MA Quality).Participate and support lessons learned activities from audits, regulatory authority inspections, and internal process deviations delivered ... (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from the internal and external study teams. This may include participation in internal and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …supported areas by dedicatedly driving compliance.Ensure readiness of records for regulatory inspections and internal audits.Ability to utilize multiple ... environment to complete tasks required to meet business objectives.Support Investigations team by providing quality and compliance input for continuous… more
- Merck & Co. (Durham, NC)
- … regulatory requirementsProvides active support during audits and inspections ( regulatory , internal , safety)Supports our Company's Manufacturing Division (MD) ... recordsTrouble-shoots equipment issues as neededInitiates and contributes to laboratory investigations as needed and follows site procedures in the documentation… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and ensuring accountability. Achieving compliance with cGMP and other relevant regulatory requirements and fostering continuous improvement are the key objectives. ... and implementing efficient and effective means of communicating with both internal and external constituents, and executing those activities, initiatives, and… more
- Merck & Co. (North Wales, PA)
- …Key Results Point for the Patient Access COEWork closely with legal and regulatory departments to ensure compliance with internal and external rules for ... company's productsBuild and manage relationships with vendors who will perform benefits investigations and other related support to help ensure that patients and… more
- Merck & Co. (Durham, NC)
- … regulatory inspections by presenting and defending technical documentation, investigations , and change controls Provide post approval support and subject matter ... Job Description Job Description: Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Sterility Assurance and Quality management during routine audits by regulatory agencies, pharma manufacturing partners and internal corporate ... auditors.Assist as a facility sterility assurance SME on product development and commercialization of new productsExperience RequirementsMicrobiology background, ideally within a sterile manufacturing site with more than one sterile production line.Two (2) or… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations , and Good Documentation Practices (GDPs).-A high level of ... technology developmentExperience with risk assessments, process characterization, validation, and regulatory authoring.Proven track record of technical innovation and sharing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and oversee production metrics. This individual will support manufacturing investigations , support and manage change controls, and maintain permanent inspection ... readiness and actively support regulatory inspections. This individual will need to build strong partnerships with Manufacturing, Engineering, and Quality to ensure… more
- RTX Corporation (Richmond, VA)
- … & Disclosures who will provide legal advice and approvals, as well as manage internal investigations related to regulatory and policy violations specific to ... Do + Manage a dynamic caseload of Global Trade regulatory and policy violation investigations + Research...+ Coordinate with RTX Consent Agreement team, contribute to internal reporting on progress to requirements, assist in drafting… more
- Amgen (Holly Springs, NC)
- …of all findings. + Drive improvements to the investigation process. + Present investigations to regulatory inspectors, internal auditors, and management. + ... + Demonstrated project management ability + Experience presenting to inspectors during regulatory inspections and internal audits. + Excellent written and verbal… more
- Charles Schwab (Westlake, TX)
- …+ You have significant experience supporting and preparing for complex litigations, internal investigations , regulatory inquiries, and corporate governance ... production, and preservation of data and documents across litigations, arbitrations, investigations , regulatory matters, and corporate governance filings. +… more
- LS Power Development, LLC (Chesterfield, MO)
- …submission of compliance reporting obligations. + Provide support with internal investigations , audits and responses to regulatory requests from federal and ... paid premium healthcare, paid parental leave and more. **About the Role:** The Regulatory Compliance Analyst is responsible for providing regulatory support and… more
- Deloitte (New Orleans, LA)
- …under investigation or in litigation and helping clients manage and respond to internal and external investigations , regulatory concerns, litigation, and ... financial accounting and reporting issues enabled by digital technologies. + Regulatory & Forensic Investigations : Assisting with compiling, analyzing, and… more
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