Quality Control Manager

Full Time

Brooklyn, New York, United States

Job description

Scismic is supporting the growth of a clinical-stage biotech company that is developing tissue engineered products in Brooklyn, NY!

We are seeking a Quality Control Supervisor/Manager to develop the Quality Control (QC) analytical procedures, specifications, testing, and verification of clinical grade tissue engineered products.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

  • Manages the activities of QC function, ensures data integrity of QC data in support of regulatory submissions.
  • Develops and troubleshoots QC analytical assays for scientific research and manufactured products, including flow cytometry, gram stain, endotoxin, ELISA, qPCR, colorimetric assays, and fluorometric assays.
  • Reviews and/or performs QC system activities such as in process, release and stability testing, information management, investigations, method validation, method transfer, instrument qualification, corrective actions/preventive actions management.
  • Authors and approves SOPs, protocols, reports, data summaries, and Certificates of Analysis for manufactured products.
  • Works in collaboration with internal Quality Assurance to establish, maintain, and improve QC cGMP compliance and documentation.
  • Oversees the effective utilization of the Quality Management System by QC laboratory personnel, develops and maintains compliance metrics and reports for management.
  • Accountable for thorough, well documented and timely laboratory deviation/investigation reporting.

MINIMUM QUALIFICATIONS

  • Bachelor’s degree in the life sciences (biology, biochemistry, biomedical engineering, or related field) is required.
  • Minimum 6 years of QC experience at a cGMP compliant cell and gene therapy company, and/or other related biologics company.
  • Supervisory experience.
  • Experience with development and implementation of methods used in testing of biological products.
  • Self-managed with impeccable organizational and record-keeping skills, and a keen eye for reviewing data.
  • Excellent oral/written communication and interpersonal skills with ability to multitask while working under restrictive timelines.
  • Comfortable with working traditional and non-traditional hours.
  • Proficient in standard Office programs like Word, PowerPoint, Excel, and standard statistical programs.
  • Previous experience working with Quality Management Systems and filing quality events.

WORKING CONDITIONS/PHYSICAL DEMANDS

  • Visa sponsorship is not available for this position.
  • No relocation assistance is provided for this position.
  • Ability to lift 25lbs or more on a regular basis.

EMPLOYMENT STATUS

  • Full-time
  • Exempt from overtime.

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