QC Supervisor

The Quality Control Supervisor will report to the QC Director.

Must have understanding and working knowledge such as Analytical assays with familiarity or expertise in the following: viscosity, turbidity, HPLC, FPLC, laser diffraction, SEM, titration. Additional experience in bioburden and or endotoxin is beneficial to have.

They will be primarily responsible for day-to-day testing.

Additional responsibilities include maintaining the day-to-day activities for product test which include managing analysts’ schedules, 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.

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.

Responsibilities

Ensure compliance with ISO 9001 regulatory requirements

Participates in Quality Control daily routines and training initiatives

Complete management of day-to-day analyst schedules and product testing requirements for the OH-coated DuloCore product line

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 mentors direct report(s) which includes setting objectives, monitoring performance and promoting development plans.

Support Customer Audits related to all QC Activities.

Qualifications

Bachelor’s Degree in Biology, Bioengineering, Chemistry, Biochemistry, Molecular Biology or related life science degree or Engineering required.

This is a QC testing supervisor role.

Candidates may be considered for the QC Supervisor or the QC Manager role based on based on education, background and experience.

Strong scientific and technical understanding and background in testing required.

Minimum of 2-7 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, team player, collaborative across all departments to achieve common goals.

A sense of urgency and efficiency to task completion mindset is needed to succeed in this role.

Experience with LEAN or 5S and continuous improvement preferred.

Demonstrated ability to foster a Quality Culture across the organization

Full-Time