- Merck & Co. (North Wales, PA)
- …to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team , the Associate Director Quality ... and other worldwide regulations and our Compa requirements.This position provides Device quality engineering and quality assurance support and leadership… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring for a Quality Assurance Document Control. The ... and approve batch records, and release batch records and finished product. The Quality Assurance Document Control individual acts as the primary liaison to… more
- Catalent (San Diego, CA)
- Catalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA Manufacturing group. A QA Associate I must be familiar with ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...organized, able to work both independently and as a team player with a positive attitude.Physical requirements: must be… more
- Merck & Co. (Durham, NC)
- …and patients on time, every time, across the globe.-The main functions of the Specialist, Quality Assurance is to assist in the review of batch records, media ... Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines,...new milestones in global healthcare.-Our Manufacturing Division is a team of dedicated, energetic individuals who are committed to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …records to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs ... regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality...leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all… more
- Insmed Incorporated (Bridgewater, NJ)
- …follow relevant regulatory GMPs and global company policies & proceduresLead overall management of Quality Assurance programs to support the QC lab and to ensure ... in other departments to increase the overall effectiveness of the Quality Assurance department.Support Statistical Trending of Manufacturing and Analytical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems ... implementations in partnership with Global DX, and QA-CSV/eCompliance team members to ensure compliant, efficient and timely completion of global DX GxP and Non-GxP… more
- Merck & Co. (Durham, NC)
- …the Vaccine Manufacturing Facility while actively participating in and embracing an empowered team culture.-The Shop Floor Quality Assurance Associate is ... Job DescriptionOur Quality Assurance group ensures every single...for quality and/or technical contribution to project team or sub- team ; may manage/ lead … more
- Eisai, Inc (Nutley, NJ)
- …incidents.Conduct annual tests and address vulnerabilities.Analyze threat data and lead hunting efforts.Deploy standards, conduct training, and track KPIs.Define ... against compliance controls.Organizational ManagementWorks with the Regional EIT Leadership Team on the service portfolio and governance required to prioritize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …programs.Ensure proactive representation of Quality professionals at strategic non-project team and at CSPV strategic discussions.Take the lead as the ... in close collaboration with the VP, Global head of Quality Assurance (RD/PV QA). CAPAs Ensure adequate...lead an efficient and effective organizationSupport the global quality annual objectives, strategic initiatives to deliver against the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is seeking a QA Investigations Lead (2nd or 3rd shift) as part of the Quality team based in Raritan, NJ. Role Overview The QA Investigations Lead has ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Catalent (St. Petersburg, FL)
- I. Department Overview: The Quality Assurance Department is responsible for providing leadership and support to the Catalent St. Petersburg site. The Department ... deliver solutions.Collaborates with management and supervisory personnel from operations, quality control and quality assurance ...when production events occur as defined by SOP and lead cross functional team to classify events… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The Quality ... experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality...portfolio of ongoing projects. Ability to work with and lead others in a team environment. Experience… more
- Tris Pharma (Monmouth Junction, NJ)
- …and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures ... and technology make us unique, but it is our team members that set us apart; they are the...Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality … more
- Merck & Co. (North Wales, PA)
- …holder through the entire product lifecycle.Key areas of focus include:the assurance of deliverable quality and process compliance,effective deliverable ... industry best-practices.Experience in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance.Ability to… more
- Merck & Co. (Rahway, NJ)
- …support investigations and provide expert opinions or technical assistance as needed. Quality Assurance and Compliance:-Develop and implement protocols and ... and methodologies.Strong leadership and managerial skills, with the ability to effectively lead and motivate a team .Proficiency in forensic tools such as… more
- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond to ... lead recruitment initiatives as required.Accountable for regional outsourcing team deliverables and compliance with global and regional processes.Ensure contract… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma. Legend Biotech is seeking QA Shop Floor Supervisor as part of the Quality team based in Raritan, NJ. Role Overview The QA Shop Floor Supervisor ... the candidate hasexperience working in an aseptic manufacturing facility, preferably in quality assurance ,manufacturing compliance, clinical quality , or cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Legend Biotech is seeking QA Investigations Supervisor (2nd shift) as part of the Quality team based in Raritan, NJ. Role Overview The QA Investigations ... Lead the daily touch point meetings with the team and monitor workload. Lead the daily...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Insmed Incorporated (Bridgewater, NJ)
- …substance sections of regulatory filings and dossiers.Sound awareness of Regulatory, Quality Assurance , and cGMP requirementsHigh energy, innovative "can do" ... Responsibilities):Responsible for being the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This… more
