What are the responsibilities and job description for the QC Analytical Supervisor position at Organogenesis?
About Us
We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our strength is giving others strength.
What You Will Achieve:
This position is responsible for providing leadership, supervision and delivery of compliant laboratory systems and data in support of Organogenesis products, and in accordance with appropriate regulatory, corporate and scientific guidelines. This position manages the QC analytical operations. In addition, this position provides oversight of studies in support of method validation, cleaning validation, process validation, and characterization activities.
How You Will Achieve It:
- Preparing and setting up the QC analytical laboratory to operational readiness.
- Supervises direct reports and schedules testing, and lab functions to meet crucial timelines.
- Ensures the lab activities are conducted in compliance with all relevant regulatory and compendial guidance.
- Demonstrates extensive knowledge in analytical test methods to support in-process, raw materials, and routine final products test samples.
- Interacts with Manufacturing and other departments to ensure support of processes and product testing.
- Performs and/or assists with laboratory testing, as needed.
- Interacts with clients during audits as a subject matter expert for QC Analytical.
- Oversee, reviews, and approves test results in a timely manner.
- Authors SOPs, OOS, deviations, trend reports, excursion reports and other quality system reports, as required.
- Oversees CoA generation of batch records.
- Supports batch record review.
- Reviews and approves testing results/documentation generated by the laboratory or is responsible and accountable for delegating this review appropriately to associates. Ensures all operations are performed with 100% compliance to cGMP/ISO documentation standards.
- Assesses procedural deviations and Out of Specification/Aberrant laboratory incidents, including providing recommendations and implementing corrective/preventative actions. Promptly conducts investigations of unexpected test results to meet testing deadlines.
- Establishes training requirements: develops, administers, and monitors the training program, maintains records in compliance with corporate and industry standards, and ensures a safe work environment.
