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Quality Control Manager
Full Time
Brooklyn, New York, United States (This job can be hybrid)
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.
*This is a hybrid role that requires 2-3 days a week onsite.
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.
*This is a hybrid role that requires 2-3 days a week onsite.
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.