- Aequor (Thousand Oaks, CA)
- …change requests approved by management. 4. Work within the Information Services and Quality Systems teams to foster good communication throughout the project ... CAPA /CC) and process improvements projects to support Corporate Quality Control. Specific responsibilities include performing investigations to support corrective… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … standards are met.Proactively assess and address operational gaps related to quality systems and compliance, fostering a culture of sustainable ... validation of IT services and determining audit targets for GxP systems .ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director, Data Quality and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …breakdowns.cGMP manufacturingCleaning and facilities managementProficient with Manufacturing Execution System (MES) Quality Management knowledge, including Change ... Legend Biotech is seeking a Facilities Cleaning Program Lead as part of the Technical Operations team...ensure the facility meets aseptic requirements for Manufacturing and Quality Control Labs. This person will communicate and provide… more
- Novo Nordisk Inc. (Durham, NC)
- …the pharmaceutical industry Demonstrated expertise in Regulations & quality systems (eg, commercial product disposition, DV/ CAPA , Change Control, Audits, ... processes. Relationships Reports to Manager, QA. Essential Functions Ensure plant systems batch release & relevant quality processes are compliant with… more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Quality Systems Lead for CAPA & Training provides leadership and ... for the effective implementation of the Quality systems and is expected to be lead ...and lead the site to meet the quality metrics for CAPA and training. Responsibilities:… more
- Hologic (San Diego, CA)
- …8 years of Quality experience with a strong emphasis in Quality Systems , Risk Management, Root Cause Analysis and CAPA . + ASQ Certification (CQA, CQE) is ... CAPA Process Lead San Diego, CA,...to support management. + Maintains detailed knowledge of relevant quality system regulations (eg, 21 CFR Parts… more
- Abbott (Alameda, CA)
- …that aid in improving the CAPA program. **What You'll Work On** + Lead , mentor and motivate a team of Quality Engineers. + Communicate confidently and ... issues. + Accountable for leadership and oversight of the CAPA system , and associated deliverables. + Provide...and the wider business around CAPA process, quality standards, and regulatory requirements. + Lead … more
- Fresenius Medical Center (Waltham, MA)
- …compliance with company procedures and FDA Regulations. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Utilizes Quality System to ensure CAPA system is ... successful and compliant. Partners with Quality Systems personnel and responsible for driving continuous improvement on...+ Must understand and know how to navigate a CAPA through the Quality System .… more
- Catalent Pharma Solutions (Harmans, MD)
- …+ A minimum of 4-6 years of progressive leadership experience + Comprehensive knowledge of CAPA , quality systems , and relevant regulations (FDA, EU, ISO). + ... Catalent employee.** **The Role:** + Oversee and manage the CAPA system , ensuring proper documentation, timely initiation,...reports on a monthly, quarterly, and annual basis. + Lead and facilitate CAPA Review Board meetings,… more
- Globus Medical, Inc. (Audubon, PA)
- …of FDA 21 CFR 820, ISO 13485, EU MDR, and global quality system regulations + Expertise in CAPA investigations, root cause analysis (RCA), and risk ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
