- AbbVie (North Chicago, IL)
- …Instagram, YouTube and LinkedIn. Job Description Purpose Oversees the plant CAPA System under Operations by performing root cause investigations for ... 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
- Bristol Myers Squibb (Devens, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Specialist , Maintenance/Reliability Engineer II executes the systems and asset ... Program against impacting policies and regulations, support of compliance investigations, CAPA , and change control impact assessments and support of health authority… more
- Kelly Services (Irving, TX)
- **QA Specialist II ** Irving, TX /Direct Hire! **Description** Kelly Science & Clinical is currently recruiting for a QA Specialist II for an analytical ... Under the direction of the Quality Manager, the QA Specialist II will assist with the overall...affect the quality of the company's services (Change Control, CAPA , internal audits, Management Review, etc.) + Oversee the… more
- United Therapeutics (Durham, NC)
- …diseases, and other orphan diseases. **How you'll contribute** The Quality Systems Specialist II will support Quality Systems and various support activities ... demonstrated experience of Quality Systems principles, practices, and processes such as CAPA , Change Control, Management Review, and Data Analysis + Knowledge of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Lead or coordinate investigations and corrective and preventive action ( CAPA ) recommendations + Interface directly with contract manufacturers and alliance ... serve as a lead/coordinator of investigations and corrective and preventive action ( CAPA ) recommendations related to manufactured products. + Works with Research and… more
- US Tech Solutions (Mettawa, IL)
- …2 days remote) have to be local- training is onsite) **Purpose:** The Specialist Quality Systems is responsible for providing quality assurance support for some or ... support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA . This position will ensure that all product, process or system related… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Gilead Company, is seeking a highly motivated individual to join us as a QC Specialist III in the QC Technical Services group within RDMC Clinical Quality Control in ... functional team members to ensure & complete the Quality records ( CAPA /Deviation) or Project/validation/qualification reports and other key deliverables in due time.… more
- WuXi AppTec (Philadelphia, PA)
- **Overview** This position is required to work on shift and be on-site. A Specialist role to provide Quality oversight in manufacturing operations at the site and ... Extensive experience writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA 's preferable. * Sound knowledge and interpretation of FDA and… more
- WuXi AppTec (Philadelphia, PA)
- **Overview** A Specialist role to provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established ... Extensive experience writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA 's preferable. + Sound knowledge and interpretation of FDA and… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …non-conformances and participate in investigation and Corrective and Prevention Action ( CAPA ) activities. + Write and revise written Standard Operating Procedures ... (SOPs) and submit procedural changes to meet corporate, divisional, plant, and regulatory requirements. + Oversee review of reports (Protocols, Qualifications, Regulatory Submissions) + Participate in QA multi-site projects as contributor, coordinator or lead.… more
- ThermoFisher Scientific (Florence, SC)
- …/ or support detailed investigations of project-related quality issues ( CAPA 's, Deviations, Audit Observations, protocols, etc.), ensuring effective corrective and ... / or preventive actions occur. Present, facilitate, and lead process improvement and PPI activities in Quality Assurance. Maintain a state of inspection readiness. Participate in self inspection, client, and regulatory audits. Other Duties if required.… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …PCR platform, Flow and ELISA. + Support completion of Quality records ( CAPA , Deviation, LIR). + Support investigations regarding out of specifications (OOS) results ... and address and manage deviations/CAPAs related to analytical procedures. + Assist in review data and assists with process trending procedural updates and other documentation. + Provides technical support for validation protocol. + Implements protocols for the… more
- ThermoFisher Scientific (Manati, PR)
- …and certifications. + Hosting Regulatory Agency and client's audits, reports and CAPA follow up. + Performing Vendor/supplier Audits, reports and CAPAs follow up. ... + Prepare Annual Product Review Reports. + Controlled Substances program support and or management. + Prepare and maintain site licensing. **Task - Safety & Compliance (5%)** + Environmental Health and Safety -identify and take actions to correct unsafe… more
- Bristol Myers Squibb (Bothell, WA)
- …. **Position Summary:** The primary focuses of the MSAT CTES Specialist are to complete deviation investigations and provide product and process ... Squibb's GMP facility in Bothell, WA. The MSAT CTES Specialist : + Is a process and product expert +...original due date + Assess, investigate and close Phase II Manufacturing Investigations of drug product out of specification… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …related to Quality Systems, Finished Product Batch Release, and Change Control. ** II . Basic Function:** This position is responsible for managing and documenting ... preparing annual product reviews; tracking, trending and follow-up of the CAPA programs. Interacts directly with the manufacturing personnel and is responsible… more
- ThermoFisher Scientific (Middletown, VA)
- …lab coat, ear plugs etc.) **Job Description** **Business Card Title: IQA Inspector II ** **Job Profile Title:** **QC Technician II , IQA** **Reports To:** **Team ... the quality system and participate as needed in the DR/ CAPA system. + Inspect materials in a timely manner...improvement. + Performs other duties as assigned. **IQA Inspector II Requirements:** + Assist in training new personnel. +… more
- System One (Fremont, CA)
- Job Title: Technical Writer II Location: Fremont, CA Hours/Schedule: 40hrs per week Compensation: $34-$42/hr Type: Contract- Start: 06/24/2024 End: 12/31/2024 ... range of uses. + Paper batch record authoring/revision/template creation + CAPA execution/follow-up for doc revisions + SOP revisions/authoring + Update/create… more
- US Tech Solutions (Fremont, CA)
- …range of uses. + Paper batch record authoring/revision/template creation + CAPA execution/follow-up for doc revisions + SOP revisions/authoring + Update/create ... training documents w/ training specialist . **Requirements:** + Familiar with a variety of the fields concepts, practices, and procedures. + Strong technical writing… more
- Kelly Services (Irving, TX)
- **QC Specialist II - Irving, TX (Pharma)** **Are you a detail-oriented scientist with a passion for quality? Do you thrive in a fast-paced environment where your ... testing services. We are seeking a highly motivated QC Specialist II to join our growing team....Systems:** Assist with internal and external audits, participate in CAPA (Corrective Action & Preventive Action) processes, and ensure… more