- AbbVie (North Chicago, IL)
- …or functions or outputs of this position. Oversees the plant CAPA Quality System by performing root cause investigations for exceptions/nonconformities/deviations to ... exception documents and timely resolution of investigations based on CAPA requirements + Coordinates the exception document process and...maintenance of the Quality System + Ensures all Quality CAPA goals and metrics are met + Promotes culture… more
- Teleflex (Olive Branch, MS)
- QMS Specialist II **Date:** Sep 18, 2024 **Location:** Olive Branch, MS, US **Company:** Teleflex **Expected Travel** : None **Requisition ID** :11018 **About ... that make a difference in patients' lives. **Position Summary** The Quality Systems Specialist II supports the development and maintenance of quality programs,… more
- Catalent Pharma Solutions (Madison, WI)
- ** Specialist II , Quality Assurance** **Summary:** _Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative ... and Catalent employee.** **The Role:** + Accountable for the Investigation and CAPA Management Systems. + Responsible for managing complex and high-level deviations,… more
- Cambrex High Point (Durham, NC)
- …Start a career where You Matter by applying today! Job Overview The QA Specialist II supports the Quality Management System (QMS) and the Document Management ... Deviations, Out of Specification Investigations, Corrective and Preventive Actions ( CAPA ), Change Control, Complaints, Quality review of analytical and… more
- ManpowerGroup (Lake Bluff, IL)
- …with a leading **Medical device** organization in the **Abbott Park, IL** for a **QA Specialist II ** role to assist their team. This is an on-site role. ... **Industry:** **Medical device** **Title:** **QA Specialist II ** **Location:** **Abbott Park, IL** **Pay...good communication, experience in a lab setting, experience with CAPA , organized with good time management **Interview preferences :**… more
- Catalent Pharma Solutions (Chelsea, MA)
- **Quality Assurance Specialist II - Night** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical ... for DPI in North America. Catalent Pharma Solutions is hiring a Quality Assurance Specialist II - Operations who is responsible for supporting operations in a… more
- Randstad US (Minneapolis, MN)
- regulatory affairs specialist ii . + minneapolis , minnesota + posted september 6, 2024 **job details** summary + $38 - $40.72 per hour + contract + bachelor ... effectively communicate at multiple levels in the organization. skills: CAPA , Regulatory Affairs Operations, Regulatory Affairs Strategy Equal Opportunity Employer:… more
- Actalent (Santa Clara, CA)
- …In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Compliance Specialist will perform work under supervision. General scope of this position is ... experience in the medical device industry. o Experience with FDA/ISO Audits, NCR, and CAPA experience is a plus. o Ability to compile and analyze data, present… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …documentation including presentation materials for assigned projects. + Lead any CAPA investigations: Lead problem solving and root-cause analysis sessions: Work ... with Quality, Engineering and Tech Service units; Manage complex investigations using DMAIC tools Ensure implementation of corrective and preventive actions + Change Controls (CC) main contact for multiple manufacturing units, including: + Multiple CCs Owner… more
- Gilead Sciences, Inc. (Foster City, CA)
- …as a lead/coordinator of investigations and corrective and preventive action ( CAPA ) recommendations related to manufactured products. + Review and approve master ... batch records, labels, specifications and other pre-production documents for clinical Drug Substance (DS) and Drug Product (DP) in compliance with FDA and international health authority requirements + Review executed production batch records, environmental… more
- LSI Solutions (Victor, NY)
- …Functions listed above, in FDA regulated environment (medical devices preferred). Regulatory Specialist II : + Bachelor or Master's degree in a technical, ... or life sciences discipline with 5-6 years' experience, relevant to the Regulatory Specialist II Essential Functions listed above, in an FDA regulated… more
- Medtronic (Plainfield, IN)
- …of patented inventions driving innovation in the healthcare space. As the **Manufacturing Engineer II ** , you will: + Participate in / Lead projects related to the ... qualification/validation + Degree in Mechanical/Electrical/Biomedical Engineering + Experience with CAPA /quality systems + Experience with six sigma and root cause… more
- Legrand NA (Canonsburg, PA)
- Position Description At a Glance Legrand has an exciting opportunity for a Testing Technician II to join the Starline Team in Canonsburg, PA. As a member of the ... correct production test issues that are not identified by the test systems ( CAPA ) + Identify opportunities for new technologies and improvements + Other duties as… more
- SpaceX (TX)
- …Quality Specialist /Level I: $75,000.00 - $95,000.00/per year Supplier Quality Specialist /Level II : $90,000.00 - $115,000.00/per year Your actual level and ... Supplier Quality Specialist (Starship) at SpaceX Starbase, TX SpaceX was...return to vendor (RTV), supplier corrective and preventive action ( CAPA ), and Production Issue Ticket review. + Support Containment… more
- ThermoFisher Scientific (Detroit, MI)
- …in bioproduction and culture media. **How will you make an impact?** The Quality Specialist II will report to the Quality Assurance Supervisor. The position's ... enterprise software systems including ERPs, electronic document control systems, CAPA and training software packages **Knowledge, Skills, Abilities** Strong critical… more
- Astellas Pharma (New York, NY)
- …are encouraged to apply. **Purpose and Scope:** The primary purpose of the Clinical Site Manager II (CSM II ) is to serve as the primary contact point between the ... Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS)...closely with CTL to ensure Corrective Action Preventative Action ( CAPA ) is completed for Quality Assurance (QA) site audits… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …timelines, and ensuring resolution per the timelines. This position supervises MSAT Senior Specialist and MSAT Specialist (I, II , and/or III). Qualifications ... analysis reports, risk assessment reports, and other product- and CAPA -related reports. Scale-up batches, equipment/systems qualifications, exhibit/registration batches, and… more
- Abbott (San Diego, CA)
- …role you will manages subordinate QA management and or experienced QA specialist employees who exercise significant latitude and independence. Often heads one or ... and vendors. + Assures that the Quality continuous improvement processes (NC's and CAPA 's) meets ARDx metric expectations for key metrics and assure that when… more