Website Accurant Biotech
Position: QA Manager
Department or Group: QA
Location: 259 Prospect Plains Road, Bldg H, Suite 168, Cranbury, NJ, USA 08512
- Schedule/conduct facility inspection, special inspection, computerized system audit, vendor/contractor audit, etc., and review SOP when necessary.
- Schedule/conduct study-based audit; including plan/protocol review, experimental phase inspection, data audit, report audit and report verification etc.
- Promptly report any inspection results in writing to management and to the Principal Investigator(s)/Study Director(s), when applicable; Follow up implementation of CAPA, when applicable.
- Sign QA statement for final report within the related GLP areas.
- Interact with client, regulatory authority, etc., during the visit/inspection.
- Lead QA group to support the GLP. Provide advice/consultation on regulatory issuesand quality management systems.
- Work closely with all levels of the management team of the company to developstrategic planning and execute the plan for the development of the QA department.
Lead the improvement on quality system.
- Hire and train new employees to build a sufficient high-quality working force toconduct quality activities. Manage/supervise the QA auditor, including performance
reviews, objective setting, and career development etc.
- Maintain, generate, and verify Master Schedule.
- Ensure appropriate and timely discard of QA records if applicable. Remove closedproject files from the active files.
- Maintain QA files, including but not limited to facility inspection files, computerizedsystem inspection files etc., and archive the files timely.
- The ability to understand the basic concepts underlying the activities being monitored. Have a thorough understanding of the Principles of GLP/GCP.
- Be familiar with the test procedures, standards, and systems.
- Be trained or have expertise and experience with the requirements of the OECD, FDA and EMA, ICH, etc., GLP/GCP guidelines as well as other applicable regulations.
- Have good communication skills, both written and verbal, and work in a team-oriented manner.
- Have good leadership and working experience in quality management. At least five years’ experience work in a GLP/GCP or GMP laboratory.
- Have an engaging and dynamic attitude towards rapid issue resolution and communication.
- BS or above in a science discipline.
- Retirement investment plan -401(k) • Vacation/PTO
- Medical, vision, and dental care
- H-1B Visa Sponsorship
Please submit your resume and CV to firstname.lastname@example.org and mention that you saw this JD on the SAPA website.