- Insight Global (Murrysville, PA)
- …based in the USA. Facilitate product and process Corrective and Preventive Action ( CAPA ) investigations from issue identification through implementation of ... Job Description This position is essential to driving CAPA activities from issue identification closure,...methods do you use for root cause analysis in CAPA investigations ? o Common tools include the… more
- US Tech Solutions (Pittsburgh, PA)
- …Actions (CAPAs) in various stages of the CAPA workflow and facilitate CAPA investigations from issue identification through implementation of solution ... stages of the CAPA workflow - Facilitate CAPA investigations from issue identification...and prepare spokespersons in representing CAPAs during audits and CAPA Review Board meetings - Lead and… 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
- Abbott (Columbus, OH)
- …and AMR Metrics. Additionally, they must work closely with cross-functional personnel to lead or support failure investigations and collaborate with other plant ... within this role include: (1) event management and responsibilities for the Abbott CAPA system, (2) project management as it relates to new product launches, trials,… more
- Reckitt (Wanamingo, MN)
- …ensure compliance to QMS. + Perform or review manufacturing non-conformances reports, CAPA , failure investigations and audit findings to report manufacturing ... Compliance Assurance Lead , (6:00 PM - 6:00 AM) City: Wanamingo...corrective action. + Prepare and analyze metrics for EM, CAPA , suppliers' performance to drive continuous improvement + Interface… more
- Lilly (Concord, NC)
- …and advise deviation reviewers and approvers on issue investigation matters. + Lead complex investigations and act as a technical reviewer for deviations and ... , participates in deviation assessments (pre-approval and post-approval), and may lead complex investigations . The Sr. Principal -Deviation Mentor also… more
- Kelly Services (Cincinnati, OH)
- …Scientific is partnering with an established biopharma CDMO to identify a ** Lead Investigator.** The Lead Investigator ensures the investigation outcome and ... concisely so as to be presentable to a regulatory inspector. + **Title:** Lead Investigator + **Location:** Cincinnati, OH metro area + **Hybrid schedule:** 3 days… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …within quality systems to generate change controls, respond to audit observations, investigations and CAPA 's. The ability to decommission equipment, revise SOP's ... **Facilities Technical Lead ** **Position Summary** Catalent, Inc. is a leading...Calipers, scales, weights, micrometers and test targets (linear measurements). Issue /Maintain CLN# tags for new equipment after checking OM… more
- Capgemini (Richmond, VA)
- …regulations) are gathered, investigated, and properly documented. . Coordinate and lead thorough investigations of product deviations, identifying root causes, ... (eg, Quality Assurance, Manufacturing, R&D, Regulatory Affairs) to gather data, perform investigations , and identify potential process improvements. . Lead and… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …the applicable regulations. Support the preparation, performance, and responses, and CAPA management to corporate quality audits. **_Supplier Audits:_** + Support ... and preventive actions, near misses derived from external inspections, including CAPA tracking. Negotiate terms with suppliers. + Coordinate with and obtain… more
- Prose (Brooklyn, NY)
- …with GMP and ISO standards. + Customer Complaints and Non-Conformance + Lead investigations into customer complaints, non-conformance issues, and deviations. + ... about and shop for personalized beauty. We're looking for talented problem solvers who lead with passion and who face any task with a positive mindset. Position… more
- Novo Nordisk (Bloomington, IN)
- …and provide insight into potential issues and suggest solutions + Ability to lead technical calls and discussions regarding investigations , audits, or other ... SME's to quickly identify the potential scope of an issue and as required escalate to Leadership to ensure...where possible and is linked to clear and actionable CAPA + Provides a summary presentation of the draft… more
- Palo Alto Networks (Austin, TX)
- …stability. + Quality Engineering & RCA: Lead Root Cause Analysis (RCA) investigations , implement Corrective and Preventive Actions ( CAPA ), and use tools like ... & Compliance: Standardize processes across sites, escalate quality issues, ensure proper CAPA implementation, and drive top- issue reduction. + Quality Metrics &… more
- Astellas Pharma (Westborough, MA)
- …+ Quality Records & Investigations : Lead or support quality investigations , risk assessments, and CAPA development. Ensure all quality records are ... will also contribute to inspection readiness, internal audits, deviation and CAPA management, and continuous improvement efforts, ensuring AIRM remains aligned with… more
- Medtronic (Irvine, CA)
- …NCR dispositions. Support Field Corrective Actions and product holds. Support Issue Investigations across Released Product Engineering. Support Remediation ... and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected,… more
- Abbott (Atlanta, GA)
- …with escalated customer complaints investigations . + Performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA ... and improvements to device software for existing products. You will plan, lead , and execute technical and cross-functional project work that may include efforts… more
- Endo International (Rochester, MI)
- …commercial products. This position also monitors, tracks, and trends Non-Conformances, CAPA , complaints and other Quality Systems, assesses the risk level associated ... with Non-Conformances and escalates the issue to management. Opportunities for continuous improvement of advanced...with contractors or other staff to ensure resolution of investigations , deviations and corrective actions, etc. + Responsible for… more
- Medtronic (Fridley, MN)
- …Responsibilities may include the following and other duties may be assigned. + Lead investigations into fielded product issues including performing the risk ... for processes such as: Non conformances, Anomaly Dispositions, Deviations, Complaint Formal Investigations , Change Control and CAPA among others. **Must Have… more
- BeOne Medicines (Hopewell, NJ)
- …and support. based in New Jersey (Hopewell), this role will be to lead the Hopewell drug product MST function to support technology transfer, validation, continued ... process verification, investigations , change management and site startup of Hopewell internal...**Leadership:** + Serve as MST DP SME and process lead for drug product, ensuring the materials, strategy and… more
- ADM (Southport, NC)
- …reports to the divisional Quality Food Safety (QFS) director. **Position Description:** + Lead a team of individuals that oversee the quality and product safety ... specification, document any noticeable discrepancy, take corrective actions to eliminate the issue + Prepare the facility for compliance during customer audits and… more