Quality Assurance Manager

GENERAL DESCRIPTION OF POSITION

The position has overall responsibility for internal quality assurance functions, which include batch release and the execution of various quality systems, including Complaints, Events (Deviations and non-conformances), CAPAs, Effectiveness Checks, Annual Product Reviews, and other quality-related tasks.

 
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 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 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. 

SUPERVISORY RESPONSIBILITIES:

Supervises employees and carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance, rewarding and disciplining employees; addressing complaints and resolving problems.

COMMUNICATION SKILLS:

Ability to read, analyze, and understand common scientific and technical journals, financial reports, and legal documents; Ability to respond to complex or difficult inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format; Ability to effectively present information to top management, public groups, and/or boards of directors.

CRITICAL THINKING SKILLS:

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal, logical or scientific symbolism such as formulas, scientific equations, and graphs. Ability to deal with a variety of abstract and concrete variables. Possess a thorough understanding of U.S. cGMPs, applicable GMPs from other regulatory bodies for which Mission Pharmacal produces pharmaceutical products, and Mission Pharmacal’s Quality Systems. Ability to maintain objectivity and perform root cause analysis. Possess excellent interpersonal and communication skills.

PHYSICAL ACTIVITIES: 

Must be able to occasionally lift and/or move up to 50 pounds; sit, stand and/or walk for periods of time; and exhibit close visual attention to work activities.