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Summary:

Processing all Standard Operating Procedures, which includes keeping the intranet site updated and maintaining the SOP training database. Compiling and processing the Annual Product Reviews for drug products and required cosmetics. Maintain Quality Management tasks in SAP workflow system.

Essential Duties and Responsibilities:

• Maintain QM tasks in SAP workflow. This includes testing and regulatory information which is very sensitive, accuracy is paramount.
• Ensuring all SOPs are processed in a manner to ensure compliance to the GMPs. This includes maintaining change control records for SOPs, issuing required review records, acquiring QA approval along with applicable department approval before making a SOP active on the intranet.
• Maintaining a SOP training database for the Tennessee site.
• Maintaining the Annual Product Review data for the site.  This includes compiling data from QC, PD, batch records, etc.  The annual reviews are for all drug products and cosmetic products for some key customers.
• Conduct the quality training portion of New Employee Orientation
• Assist with customer specification requests
• Assist QA Management with special projects as requested.

Supervisory Responsibilities:

None

Competencies:

• Must demonstrate a working knowledge of chemical analysis and laboratory bench work. 
• Must have a working knowledge of computer usage including experience and ability to troubleshoot in SAP, spreadsheets, word processing, and database packages. 
• Must understand FDA regulations that are relative to product testing.
• Requires excellent oral and written communication skills.
• Excellent organization skills.
• Ability to analyze data.
• Ability to handle stress and work with multiple priorities independently.
• Ability to interface effectively with other departments.
• Demonstrates excellent analytical and decision-making ability. 
• Must be able to work on multiple projects in a fast-paced environment and critically review analytical and related data to prepare technical reports in accordance with all cGMPs. 
• Must be able to coordinate workload and work under pressure. Has a professional, helpful attitude accepts constructive criticism well, and is a team player. 

Certificates, Licenses, Registrations:

None

Travel:

Limited

Work Environment:

CRITICAL TO JOB: Standing and walking-70% of time on job; sitting-30% of time on job; climbing stairs and ladders-12 times a day; repeated motion of hands (typing)-30% of time on job; communicate (talking and listening)-75% of time on job; identifying colors-20% of time on job, ability to see, weight lifted or force exerted up to 20 lbs-50% of the time. HELPFUL TO THE JOB, NOT CRITICAL: Ability to bend, stoop, and kneel and the ability to visually track moving objects.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

Education Requirements:

A Bachelor’s degree in a related field is preferred. 

Experience Requirements:

• Proficient in Microsoft Office products including a minimum of 2 years computer software experience in a work environment. Proficient in Excel; basic understanding of Word.
• QA, QC or working in a GMP environment is preferred.
• Basic laboratory skills required including pipetting and analytical dilutions.