What are the responsibilities and job description for the Quality Control Supervisor position at STC Biologics Inc?
Company Description STC Biologics Inc. is a biotechnology company based in Cambridge, MA, specializing in the development of biologic drugs with a strong focus on biosimilars. The organization is known for analytics-driven process development and works across the full drug development lifecycle, from target selection to IND/CTA filing and BLA/MAA submissions. STC Biologics partners with pharmaceutical and biotechnology companies to accelerate development timelines and address challenges in analytical and process development. Team members collaborate in a science-focused environment that emphasizes innovation, data-driven decision making, and practical solutions for complex biologics programs.
Role Description The Quality Control Supervisor is a full-time, on-site role located in Newton, MA. This position oversees daily quality control testing activities in the laboratory, ensuring that biologics and biosimilar products meet internal specifications, regulatory requirements, and industry standards. The supervisor manages QC staff scheduling and workload, reviews and approves test results, and maintains documentation, SOPs, and QC-related records. Responsibilities include coordinating assay qualification and validation, monitoring laboratory equipment calibration and maintenance, and supporting investigations, deviations, and CAPAs in collaboration with Quality Assurance. The role works closely with process development, analytical development, and manufacturing teams to support batch release, continuous improvement initiatives, and readiness for regulatory inspections and audits.
Qualifications
- Candidates should possess strong Quality Control and laboratory skills, including experience with biologics testing methods, data recording, and adherence to QC procedures.
- Candidates should possess solid Analytical Skills and Quality Assurance knowledge to interpret complex data sets, support investigations, and ensure compliance with cGMP and regulatory standards.
- Candidates should possess effective Supervisory Skills to lead QC staff, provide training and mentoring, assign tasks, and manage performance in a laboratory setting.
- Candidates should possess proficiency with documentation systems, laboratory information management systems (LIMS), and standard office software used for reporting and communication.
- Bachelor’s or Master’s degree in a relevant scientific discipline (such as Biology, Chemistry, Biochemistry, or related field), and prior QC experience in biopharmaceutical or biotechnology environments.
- Strong organizational, communication, and collaboration skills, with the ability to work cross-functionally and support inspection readiness and continuous improvement activities.