- Astellas Pharma (Westborough, MA)
- ** Investigations and CAPA Lead ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are ... programs. AIRM is headquartered in Massachusetts. Astellas is announcing an ** Investigations and CAPA Lead ** opportunity at their **Astellas Institute for… more
- Cook Medical (Pittsburgh, PA)
- … self-developed departmental initiatives* Remains qualified to participate in and/or lead investigations activities and actively does so as needed/required* ... others, and driven by integrity, we invite you to apply. The Manager, Investigations , CAPA and Complaints at Cook MyoSite, Inc. is responsible for overseeing all… more
- CBRE (Concord, NC)
- …Partner with CBRE Quality to lead or support investigations and CAPA 's + Lead investigations and develop countermeasures and improvements to prevent ... Facilities assets and infrastructure including Central Utility Plant + Lead Root Cause Analysis for any Central Utility alarm...team as needed **Emergency Response / Fire Systems** + Lead on emergency response issues where there is an… more
- US Tech Solutions (Pittsburgh, PA)
- …critically review Corrective and Preventive Actions (CAPAs) in various stages of the CAPA workflow and facilitate CAPA investigations from issue ... and Preventive Actions (CAPAs) in various stages of the CAPA workflow - Facilitate CAPA investigations...and prepare spokespersons in representing CAPAs during audits and CAPA Review Board meetings - Lead and… more
- Insight Global (Murrysville, PA)
- …compliance. 1. What tools or methods do you use for root cause analysis in CAPA investigations ? o Common tools include the 5 Whys, Fishbone (Ishikawa) Diagram, ... in the USA. Facilitate product and process Corrective and Preventive Action ( CAPA ) investigations from issue identification through implementation of solution… more
- Philips (Cambridge, MA)
- …processes. Leading and mentoring a team of quality professionals, providing guidance on CAPA investigations and documentation. **You're the right fit if:** + You ... The Senior Quality Manager- CAPA will play a critical role within Philips'...management skills (MS Project preferred) with the ability to lead multiple initiatives simultaneously. + You have a minimum… more
- Abbott (Livermore, CA)
- …with regulatory requirements and internal quality standards. **What You'll Work On** + Lead the CAPA process and Complaints Handling Process at all sites. ... helping address some of the World's greatest healthcare challenges. As the Senior CAPA & Complaints Specialist, you are responsible for managing the Corrective and… more
- Abbott (Columbus, OH)
- …metrics and reports and establishes further actions, as may be required. + Approves CAPA investigations and resolution plans, verifies completion of CAPA ... and ensure the CAPA process is compliant and effective and driving investigations to root cause. + Identify opportunities to proactively assure compliance to all… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose The Manager, CAPA & Post-Market Surveillance ("Manager") is part of AbbVie's Medical Device ... trends, manages the actions to resolve manufacturing and supplier issues (eg, CAPA ), and serves as process owner for Post-Market Surveillance Reporting. The Manager… more
- Danaher Corporation (Fargo, ND)
- …change controls. In this role, you will have the opportunity to: + Lead and author deviation investigations including root cause analysis, trend investigation, ... and impact assessment + Manage Change Controls and CAPAs from initiation to closure + Perform document revisions including laboratory procedures and forms + Collaborate with cross-functional teams to drive problem solving and continuous improvement + Address… more
- Lilly (Lebanon, IN)
- …local and corporate regulatory requirements. + Enter Trackwise events, participate in and lead CAPA investigations + Troubleshoot and diagnose process ... successful startup into GMP manufacturing operations. **Position Brand Description:** The Lead Operator for API manufacturing operations is directly responsible for… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Process Mapping / Flow Charts, Interviews and brain storming + Reviewing the adequacy of CAPA -s with respect to the root cause investigations . To verify if the ... able to identify and notify atypical product quality trends while review of investigations . Lead and develop quality systems personnel and drive quality culture… more
- Boehringer Ingelheim (Athens, GA)
- …Participates in 3rd party audits as assigned by management. + Serves as a "co- lead " for audits/inspections. + Serves as an SME for strategy rooms during internal and ... Business/Technical Knowledge, Communication, Delivering Results, Innovation & Change, Lives Lead & Learn, Quality Orientation/BPE, Teamwork/Collaboration, Knowledge of Regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …Program Quality, Deviation Management and Serious Breach review board meetings. + Lead complex quality investigations impacting the clinical trial delivery ... Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of deviation management… more
- ManpowerGroup (Fremont, CA)
- …and process validation, and review associated documentation. + Investigate non-conformances, lead CAPA investigations , and implement corrective actions. ... Fremont, CA** **Pay Range: $ 33-38/hr (W2 Contract)** **What's the Job?** + Lead and support new product development projects to ensure compliance with quality… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …working hours may be required as needed. **How you will contribute:** + Lead Deviations/ CAPA investigations + Collaborate with multiple cross functional ... the role:** Applicants to this role will be responsible of managing investigations and Corrective/Preventive Actions ( CAPA 's) for manufacturing operations and… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …regular** **meetings with Global Quality for alignment as required.** **Support the** **Global PV** ** CAPA & Deviation lead in the management of PV related Audit ... CAPA implementation and** **documentation.** **Facilitate discussions with CAPA owners to drive completion of investigations ,...closure of CAPA .** **Support** **the Global PV** ** CAPA & Deviation lead ** **to develop, coordinate… more
- Pentax Medical (Montvale, NJ)
- …is vital to the functionality of cross departments to ensure timely CAPA evaluations/ investigations , determining root causes and effectively implement the ... and Holiday policy. Want More INFO? The Senior Quality Engineer will lead and implement quality improvement, remediation initiatives, and facilitate the change… more
- Actalent (Minneapolis, MN)
- …provide process analyses and oversight on a continuing basis. Responsibilities + Act as CAPA Specialist to keep the CAPA portfolio for the Cardiac Surgery ... Operating Unit and Parker CAPA board on track with detailed timelines. + Work...portfolio review and file meeting minutes and presentations. + Lead audit and inspection preparation, resolve audit and inspection… more
- Sanofi Group (Framingham, MA)
- … investigations , independently lead process risk/gap assessments, investigations , change controls & CAPA implementation. Is part of ... product introduction, process transfer & validation, shopfloor support and lead process investigations . The MSAT Drug Substance...MSAT Drug Substance Lead is expected to lead complex and/or multi-step deviations & CAPA … more