Quality Control Principle Scientist

Portsmouth, NH

Posted: 05/02/2019 Job Number: JN -052019-10734

Quality Control Senior/ Principle Scientist

Job Description Summary

Act as a senior team member of the Quality Control department to support technology transfer, validation, deviation support, and investigation projects. Subject Matter Expert for all applicable disciplines. Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles, and may impact future concepts, products, or technologies. Supports the review of all regulatory documents including APRs and BLAs. Direct contact with customers and project teams. Acts as adviser to leadership staff to meet schedules and/or resolve technical problems. Troubleshoot assay and instrumentation issues involving data mining, trending and analysis to identify problems. Provides hands-on and theoretical training as appropriate for QC and other operational groups. Recognized by site and industry as a technical leader. Maintains current with industry practice and trends through seminars, research, bench-marking.

- Acts as adviser to leadership staff to meet schedules and/or resolve technical problems

- Represent QC and the company in customer meetings to receive/deliver information, request and requirements.

- Document review for transfers/validations/Deviations/Investigations

- Measures throughput, performance and other appropriate metrics and report them to management.

- Maintains an awareness of site safety objective and ensures these are communicated and adhered to in the QC department.

- Develop the technical, GMP and leadership skills of QC personnel and perform mid-year and annual reviews of supervised QC personnel (if relevant).

- Demonstrated leadership of either direct reports or indirect reports through a Project Team. Must have experience in resolving conflict within a project team and

be able to influence to redirect the team as required.

-Long term, the position may have direct reports of junior staff within the department-


Bachelor's degree in Biochemistry, Chemistry, Engineering, or relevant scientific specialty. Master's or Doctorate degree preferred.

Extensive experience in a GMP environment

Experience in Validations, Qualifications and Transfers of analytical methods to a QC environment

Excellent troubleshooting skills and ability to successfully train junior staff

Encourage a positive team working environment where peers and team members feel encouraged to learn from this candidate

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