Quality Control Supervisor/Manager

Company Overview & Position Description

  • EpiBone is a clinical-stage company that develops revolutionary tissue engineered products for skeletal repair, and is offering the chance to work with the company to support the clinical translation of innovative regenerative stem cell therapies. 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 5-7 years of QC experience at a cGMP compliant cell and gene therapy company, and/or other related biologics company.
  • 1-3 years of 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.

**Qualified applicants, please submit your Cover Letter and Resume for consideration to: carla@epibone.com**

  • EpiBone, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, gender, gender identity or expression, religion, sex, sexual orientation, national origin, age, disability, or genetics. In addition to federal law requirements, EpiBone ,Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.