Job Type: Full-time
Salary: $140,000.00 to $150,000.00 /year
The Quality Assurance Director leads the company's Quality Assurance activities, oversee cGMP compliance initiatives and manages QA resources. The Quality Assurance Manager will interact with all areas and levels of the company, in addition to regulatory agencies and vendors, to ensure applicable standards, regulations and guidelines are followed in the manufacture of company products.
Responsibilities include, but are not limited to:
- Maintain an up-to-date knowledge of current Good Manufacturing Practice (cGMP) regulations and FDA guidelines applicable to company operations.
- Develop and maintain company quality documents such as product specifications and operating procedures - in conformance with cGMP standards.
- Manage team performing quality inspection of incoming raw materials, in-process manufacturing QA functions, finished goods release and preparation of job documentation.
- Experience in qualifying suppliers through scheduling and review of GMP audits.
- Works directly with manufacturing, packaging and warehouse departments to ensure Quality Control requirements are met.
- Coordinate and execute cGMP related training of company personnel.
- Manage the nonconformance program including deviations, root-cause analyses and CAPAs. May require leading investigations and/or writing investigation reports for other departments.
- Investigate and provide detailed findings of customer complaints, including risk assessments.
- Develop effective partnerships with internal staff and external organizations to facilitate problem solving and resolution of issues.
- Provide support for site visits or audits conducted by clients or regulatory agencies.
- Experience interacting with the FDA.
- Detailed knowledge of 21 CFR Parts 11, 210, and 211, ICH guidelines, and USP/NF criteria.
- Manage and lead the company during FDA, external, and internal audits and in the preparation of responses to any audit observations.
- Bachelor's degree in science, technology, engineering or math related discipline.
- 7+ years of experience in quality assurance/control of FDA regulated manufacturing operations.
- Experience with hiring, training and day-to-day supervision of Quality personnel.
- Strong working knowledge of statistical methods and analytical frameworks for problem solving.
- Experience writing SOP's, CAPA's, deviations, etc., and the ability to translate GMP/FDA guidelines into clear & effective protocols.
- Knowledge of regulatory requirements that affect pharmaceutical manufacturing.
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