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

1. Serves as the quality subject matter expert related to all quality matters involving Mission’s manufacturing, packaging, warehousing and supporting operations.
2. Reviews and approves Mission’s GMP Master documents and oversees release of manufactured batches.
3. Responsible for the Internal Audit and Supplier Audit Programs.
4. Reviews and approves change controls. Will either facilitate or review and approve deviations, CAPAs, non-conformances, and customer complaint investigations.
5. Communicates any Quality matters with Mission’s customers as agreed upon in Quality Agreements.
6. Facilitates and hosts customer audits to support review of Mission’s manufacturing and quality systems.
7. Participates/supports Regulatory audits of the facility by the FDA and other health authorities.
8. Assist in the coordination and approval of annual product reviews; and sharing of approved reports with business customers (as required per contract).
9. Conducts routine introductory training of new hires on the basic GMP requirements needed for the Pharmaceutical industry.
10. 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.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty mentioned satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

COMPENTENCIES

Core Competencies
Innovative Thinking - Looks for CREATIVE and innovative approaches/ideas that will improve efficiencies and/or provide solutions to workplace issues or concerns. EMBRACES CHANGE, champions new ideas and encourages others to do the same.
Customer Focused - Demonstrates FIERCE DETERMINATION in ensuring that services and/or solutions for internal and external customer expectations and needs are always met; incorporate flexibility as needed.
Effective Communication - COMMUNICATES appropriately and knowledgeably in order to effect a desired outcome. Able to clearly present information through the spoken or written word. Listens to others.
Reliable Team Player - Adds complementary skills and consistently contributes valuable ideas, opinions and feedback. COLLABORATES well amongst internal and external teams.
Results Driven - The ability to attain goals and objectives. Takes PERSONAL RESPONSIBILITY and ACCOUNTABILITY for their own decision making and thinking.

Functional Competencies
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continually build knowledge and skills; Shares expertise with others.
Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively, influence actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
Delegation - Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results.
Managing People -Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates’ activities; Available to staff; Provides regular performance feedback; Develops subordinates’ skills and encourage growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services; Continually works to improve supervisory skills.
Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.

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.