- Aequor (Houston, TX)
- …and knowledge with others across the team o Routine interaction with Quality Assurance (Raw Materials) and other interdepartmental members to communicate ... Quality Records (such as deviations, material recalls, and CAPA ) in partnership with applicable SMEs. Leads error prevention...to work well within a team. Routine interaction with Quality Assurance and other Quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensuring the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections across the organization ... and that evidence is archived.Ensure up to date audit CAPA information in the eQMS in a timely manner.Support...completion for all outsourced audits with Development and Medical QA , PV QA , QMS and stakeholders.Collaborate with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... quality systems processes.Key Responsibilities Provide oversight to the CAPA program for the CAR-T manufacturing site.Oversee metrics, trending, and reporting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and in a manner which meets their expectations Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....analysis utilizing Standard Problem Solving (SPS) methods and strong CAPA development within the NN deviation IT platform Serve… more
- Repligen (Waltham, MA)
- …the biotechnology industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product ... meetings with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance .Maintain internal and external audit schedules; serve… more
- AUROBINDO (Durham, NC)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... entries in ERP system related to the department.To write the deviations and CAPA for the departmental activities.Perform any and all additional tasks relating to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for risk mitigation.Support the stakeholders in identifying and defining quality improvement initiatives for development activities / programs post internal ... system audit.Support reporting of quality metrics for audits and inspections and execute against...ensure compliance to regulatory guidelinesEnsure up to date audit CAPA information in the eQMS in a timely manner.… more
- Twist BioScience (South San Francisco, CA)
- …the company. Examines, stocks, and distributes materials in inventory.Assist with QA assessments for discrepancy reports related to material handling.Maintain a ... Material Handler is also responsible for maintaining and continuouslyimproving the quality system and achieving quality objectives through daily actions.Minimum… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes, ... will work closely with process owners, subject matter experts (SMEs) and Quality colleagues within R&D and cross-functionally, to facilitate, roll-out and track… more
- Sokol Materials & Services (Skillman, NJ)
- QA Lead Technical Operations - CAPA Job Location...or GXP with at least 8 years focused on product quality . Preferred Active member of ASQ or ISPE. + Prior ... environment. About the Role DUTIES AND RESPONSIBILITIES: * Provide QA support to the Devens site and QA...Make decisions on non-conformances using a solid understanding of Quality Systems and regulatory requirements. * Review and approve… more
- Abbott (Alameda, CA)
- …+ Minimum 8 years in Quality or related field experience. + Previous CAPA and/or Quality Assurance /engineering experience and demonstrated use of ... subject matter expertise during audits and inspections. + Represent CAPA QA in cross functional meetings (site...and routinely mentors/leads other members of the organization on quality assurance practices. + Complies with US… more
- Caris Life Sciences (Phoenix, AZ)
- …Manager, CAPA & Complaints position provides quality oversight of the CAPA and Complaints Quality Assurance processes at Caris Life Sciences. ... where your impact begins.** **Position Summary** As part the Quality Assurance team at Caris Life Sciences,...management to identify opportunities for process improvement based on CAPA , Deviation, Quality Event, and Complaint metrics.… more
- Cook Medical (Pittsburgh, PA)
- …a cell therapy product in an FDA-regulated environment.* Experience in Quality Assurance and/or Compliance functions and Investigations/CAPAs including at ... and driven by integrity, we invite you to apply. The Manager, Investigations, CAPA and Complaints at Cook MyoSite, Inc. is responsible for overseeing all activities… more
- Abbott (Alameda, CA)
- …engineering and/or technical operational experience plus demonstrated competence. + Previous CAPA and/or quality assurance /engineering experience and ... issues. + Participate in, or lead, the completion of CAPA projects, assuring compliance, quality and timeliness...electronic system. + Execute and provide on-time completion of Quality Assurance engineering deliverables. + Provide support… more
- ManpowerGroup (Gretna, LA)
- …As a CAPA Process Analyst II, you will be part of the Quality Assurance department supporting cross-functional teams. The ideal candidate will have strong ... collaborative mindset which will align successfully in the organization. **Job Title:** CAPA Process Analyst II **Location: Gretna, LA** **Pay Range:** $30 - $33/hr… more
- Catalent Pharma Solutions (Greenville, NC)
- …investigations (OOS), CAPA and change control. + Demonstrated experience leading Quality Assurance teams in commercial manufacturing QA to maintain ... **Associate Director, Commercial Quality Assurance ** **Position Summary** Catalent, Inc....(CMOs and CPOs). **The Role** + Act as Commercial QA SME during FDA, non-domestic and client audits and… more
- Bristol Myers Squibb (Devens, MA)
- …here at BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As Shift Manager for the A2 Shift (6pm to 6am), you will ... lead a team of 4-8 Specialists. The Shop Floor Quality Assurance team is responsible for 24x7...operational issues. + Accountable for the performance/delivery of the QA field quality organization, including oversight of… more
- Nitto Denko Corp. (Milford, MA)
- …Biology, Pharmaceutical Sciences, or related discipline. + 5+ years in GMP Quality Assurance within the pharmaceutical or biotech industry. + Experience ... About this opportunity : The Senior Quality Systems Specialist, QA will be...metrics to QA leadership. + Act as QA Reviewer for Deviations and serve as CAPA… more
- Abbott (Columbus, OH)
- …Our 114,000 colleagues serve people in more than 160 countries. **Project Leader Quality Assurance - Ingredient Supplier Quality ** **Working at Abbott** ... location in the **Nutrition Division** . Our Global Supplier Quality Assurance (GSQA) group in Columbus, OH...has an opportunity for a Project Leader, Ingredient Supplier QA . The primary function of the GSQA group is… more
- SLAC National Accelerator Laboratory (Menlo Park, CA)
- …provide advisory support for the projects. This position will report directly to the SLAC Quality Assurance ( QA ) Deputy Director of Quality Assurance ... Construction Quality Assurance Specialist-Program Manager Job ID...Assists the project QAM in oversees each project's construction quality performance by developing and monitoring construction QA… more
