QC Supervisor

Repligen Quality Control Supervisor

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The Quality Control Supervisor will report to the QC Senior Manager. Must have understanding and working knowledge such as analytical assays with familiarity or expertise in the following : viscosity, turbidity, HPLC, FPLC, laser diffraction, Camsizer, SEM, titration. Additional experience in bioburden and / or endotoxin is beneficial. 100% on site role as a working QC supervisor, primarily responsible for day-to-day testing.

Additional responsibilities include maintaining the day-to-day activities for product testing which include instrument calibration, validation, batch record reviews, document revisions, IOPQ qualification documentation and execution.

This role will also provide support with document writing, document revisions, and handling investigations. Must have thorough understanding of Good Documentation Practices (GDP), identification and review of deviation investigations and Out of Specifications (OOS) results, and responsible for nonconforming product controls.

Availability in early mornings and late evenings to work cross functionally with stakeholders abroad. Must be willing to travel both domestic and internationally as required. Responsible for continuously improving and executing the Quality Control Plan.

This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This position is likely to expand to include coaching, guidance, and supervision of up to two direct report analysts in the future.

Ensure compliance with ISO 9001 regulatory requirements. Participates in Quality Control daily routines. Develop, Monitor and Compile Quality metrics for daily tier meetings, Operations meetings and annual management review meetings.

Review of validation plans / reports, deviations, root cause and corrective action plans prior to implementation. Assists with troubleshooting OOS investigations, OOT investigations and NCMR investigations. Supervise and mentor direct report(s) which includes setting objectives, monitoring performance and promoting development plans.

Support Customer Audits related to all QC Activities. Future responsibilities likely to include management of analyst's day-to-day functions. Including but not limited to, ensuring compliance with training initiatives, developing and planning out analysts' schedules, and fulfillment of product testing requirements for the OH-coated DuloCore product line.

Bachelor's Degree in Biology, Bioengineering, Chemistry, Biochemistry, Molecular Biology or related life science degree or Engineering required. This is a full time, on site, working QC testing supervisor role. Candidates may be considered for the QC Supervisor role based on education, background and experience. Strong scientific and technical understanding and background in analytical and wet chemistry testing required.

Minimum of 3-6 years of experience with testing methods as an analyst and / or supervisor in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required. Knowledge and experience with USP Methods and the ability to apply updates as required. Minimum 1 year of experience mentoring other QC staff. Strong attention to detail. Enthusiastic, self-starter who is a team player. Willingness to work collaboratively across all departments to achieve common goals. A sense of urgency and efficiency to task completion mindset is needed to succeed in this role. Comfortable working in ambiguity and utilizing skillsets to navigate complex situations. Experience with LEAN or 5S and continuous improvement preferred. Demonstrated ability to foster a Quality Culture across the organization.