Quality Control Director
Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding.
Please refer to these associated links to learn more about Cresilon:
The QC Director oversees the entire Quality Control Department, including analytical chemistry, microbiology, and in-process control efforts. The QC Director is authorized to sign-off on testing monographs. The QC Director is ultimately responsible for verifying that all specifications within a product's Device Master Record (DMR) conform to their predefined acceptance criteria.
- Manage QC Department, including staff and laboratory activities.
- Develop QC department protocols and procedures for operation.
- Manage all daily aspects of QC laboratory including but not limited to, testing, instrumentation, release testing of raw materials and finished products.
- Manage and execute analytical method validation.
- Manage and execute QC equipment qualification (IQ,OQ,PQ), with help as needed.
- Assist in the review of all quality-related documents.
- Work with VP, QARA and other company leadership to evaluate existing manufacturing practices in terms of cGMP, sterility assurance and regulatory compliance and make recommendations for process improvements.
- Draft job descriptions, company policies, and programs as related to the QC Department.
- Develop and conduct departmental cGMP and SOP training program in coordination with QA Manager.
- Understand and abide by the policies detailed in the Employee Handbook.
- Provide SME for customer audits and regulatory audits.
- Ensure QC decisions align with Quality System, GMP and regulatory requirements
- Recommend QC strategic objectives.
- Demonstrate technical proficiency in analytical methodology, microbiological methods and adherence to GMP and ICH compliance and/or conformance
- Evaluate resource requirements to support routine work and special projects and assure projects remain within budget.
- Lead QC continuous improvement initiatives including implementation of new methods and equipment.
- Track QC metrics and takes appropriate action to improve lab performance.
- Represents QC on cross-functional project teams.
- Oversee environmental monitoring program.
- Participate in CAPAs, investigations, and change control committees.
- Bachelor's degree in Microbiology, Biology, Chemistry or related scientific discipline.
- Master’s degree in the relevant fields is strongly preferred.
- 10+ years of laboratory experience in cGMP regulated environment.
- 4+ years of medical device experience.
- 5+ years of supervisory or managerial experience.
- Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:2007.
- Working knowledge of FDA requirements as per 21 CFR 820.
- Working knowledge of Good Documentation Practices (GDP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP).
- Experience should include method development/validation and/or transfer/verification, protocols, and trouble shooting skills.
- Requires understanding of microbiology testing, analytical testing, and quality principles as applied to a cGMP environment. This includes experience in raw material, in-process and finished product testing, e.g. bioburden, endotoxin studies, sterility assurance, appearance, cleaning methods, HPLC and rheometer.
- Proficient in the use of Microsoft Excel and Microsoft Word.
- Requires strong leadership skills, excellent communication and presentation skills.