Quality Manager

MUST HAVE

Performing audits for

FDA ESSENTIAL DUTIES AND RESPONSIBILITIES

Serves as the quality subject matter expert related to all quality matters involving Mission's manufacturing, packaging, warehousing, and supporting operations. Reviews and approves Mission's GMP Master documents and oversees the release of manufactured batches. Responsible for the Internal Audit and Supplier Audit Programs. Reviews and approves change controls. Will either facilitate or review and approve deviations, CAPAs, non-conformances, and customer complaint investigations. Communicates any Quality matters with Mission's customers as agreed upon in Quality Agreements. Facilitates and hosts customer audits to support review of Mission's manufacturing and quality systems. Participates/supports Regulatory audits of the facility by the FDA and other health authorities. Assist in the coordination and approval of annual product reviews, and sharing of approved reports with business customers (as required per contract). Conducts routine introductory training of new hires on the basic GMP requirements needed for the Pharmaceutical industry. Works with the Director of Quality Systems and Technical Services on continuous improvement projects for existing processes and Quality Systems. Perform any other related duties as required or assigned.

EDUCATION AND EXPERIENCE

Bachelor's Degree and at least 5 years of related experience and/or training; or equivalent combination of education and experience.

Pay:

$90,000.00 - $110,000.00 per year

Benefits:

Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person