Job Summary

Manages the plant Quality Assurance Staff.  Responsible for implementation and maintenance of related Good Manufacturing Practices (GMP), Document Control, and the Quality Program for that plant. Part of the East Coast Management Team.

Reasonable Accommodation

Essential duties, responsibilities, and qualifications of the job can be performed with or without reasonable accommodation and without posing a direct threat to him/herself or others.

Duties and Responsibilities

Essential

·       Quality Assurance experience relating to inspection programs: AQL sampling plans, quality systems, defect elimination and prevention (corrective action/preventative action), investigations and analysis, etc.

·       Conducts / coordinates internal audits of plant for compliance to GMP.

·       Keeps the plant audit ready at all times for contract manufacturing and regulatory agencies

·       Acts as liaison with FDA and other regulatory agencies during routine inspections.

·       Develops documentation and interacts with Document Control for changes for the plant QA program.

·       Maintains the plant Microbiology and QA physical laboratories and coordinates the testing of plant bulk batches and ingredients for conformance to specifications.

·       Coordinates the implementation of quality programs for new processes and technologies.

·       Coordinates the sample/ingredient retain program.

·       Works with vendors and purchasing to assure conformance to specifications of incoming labels, components, ingredients, and outside-manufactured products.

·       Coordinates with the Lab Manager in the maintenance of laboratory equipment and instruments in conformance to GLP guidelines.

·       Interacts with plant management to assure GMP awareness and compliance, as well as be part of that management team.

Additional

·       Performs other duties as assigned or needed.

·       Destruction or storage of outdated documents according to guidelines.

Supervision of Others

·       Provides direct supervision to QA lab staff and inspection technicians by performing such duties as determining employment status (i.e. hiring, terminating, promotions, issuing warnings, etc.), interviewing applicants, counseling, training, scheduling, resolving conflicts, coordinating with other departments, conducting employee meetings, recommending wage increases, etc.

Minimum Qualifications

Essential

·       Bachelor’s degree (or better) in a related science with 3+ years industry Quality Assurance supervisory experience.

·       Working knowledge of Quality Assurance sampling and statistical process control.

·       A working knowledge of Federal Regulations regarding the manufacturing and distribution of drug products and/or experience in pharmaceutical (or medical device) Quality Assurance, including experience in component and finished product inspection.

·       Excellent verbal and presentation skills.

·       Ability to organize and coordinate projects.

·       Ability to manage a department budget.

·       Ability to perform multiple tasks in a fast paced setting.

·       Ability to perform duties with efficiency and accuracy.

·       Statistical and data analysis skills.

·       Computer word processing, spreadsheet, and database skills.

Additional

·       Ability to climb stairs.

·       Ability to travel occasionally

*Position is located in and requires relocation to Knoxville, TN. Relocation will be provided as well as a possiblity of housing assistance and sign-on bonus.