Quality Assurance Manager – VIA Jon

Krisa Whaley  advised on 9/8/15 that the position had been filled.

I am glad that she wanted to let Section 1304 Members know that she has transitioned out of the the QA Mgr role at VIA-JON into a new Compliance role in their legal department which has created this opening. She can be contacted at kwhaley@vijon.com for more insights. If you are interested and qualified, she has offered to provide introductions.

The job is posted at www.vijon.com under Career Opportunities

QUALITY ASSURANCE MANAGER ? Help Please fill in the information below and use the navigational buttons to continue. Warning: Using your browser’s Back and Forward buttons may produce undesirable results. POSITION SUMMARY: Manage all aspects of the Quality Assurance Function. Ensure compliance with FDA and GMP regulations. Direct compliance of government regulations; advise, instruct and recommend policies to ensure compliance. Responsible for overall quality system implementation and management, including the TQM program. FUNCTIONS OF THE JOB: Essential Functions 1. Behavior: Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day 2. Attendance: Present for work when scheduled is a mandatory function. 3. Safety: Your compliance with all company safety rules, procedures and guidelines is essential. 4. Develop, implement, and maintain quality specifications and standards for components and finished goods. 5. Ensure GMP required documentation and compliance with governmental regulations such as FDA. 6. Estimate departmental personnel needs, interview job applicants and recommend candidates for employment. 7. Train departmental employees, conduct timely performance evaluations, provide coaching/mentoring, and assist employees with work related problems. 7. Provide technical assistance and interface with other departments in connection with the purchase of raw materials, supplies and equipment. 8. Review complaints received from customers to determine where quality emphasis should be placed to eliminate the problems. 9. Perform investigation and evaluation of the non-conforming materials, processes and system. Present problem areas or issues as they arise, providing recommendations for solutions. 10. Monitor and interpret Federal Register and other sources including interaction with regulatory department that provide information on laws pertaining to Food, Drugs and Cosmetics industries. Advise and inform management on state and federal regulations, recommend procedures and policies to ensure compliance with government regulations. 11. As requested, check documents for compliance with state and federal law; verify accuracy. 12. Recommend, conduct, and/or oversee all employee training on GMP, FDA and SOP. 13. Continually evaluate and analyze all phases of the production process, which are related to quality, in order to ensure adherence to applicable standards and specifications. 14 Conduct internal facility audits and prepare necessary reports. 15. Provide trend analysis for non-conforming and preventative issues, complaints, corrective actions, deviation processes, results of internal/external audits, quality system and improvements. Marginal Functions None identified. Physical Activities: Standing, sitting, walking, grasping, talking, hearing, and stooping. Physical Demands: Light physical work. Employee required to exert up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. Visual Acuity: Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust the eye to bring objects into sharp focus. Prolonged mental attention. Environmental/Atmospheric Conditions: Worker exposed to typical office conditions. Exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. POSITION QUALIFICATION REQUIREMENTS: Knowledge: Thorough working knowledge of chemistry and quality systems. Bachelor’s degree in chemistry and/or related science. Must have excellent oral and written communication skills. Thorough knowledge of pertinent laboratory instrumentation. Experience: Requires five to seven years progressive quality control experience performing a variety of chemistry and quality functions. A minimum two years quality control management working in a FDA environment, preferably in the pharmaceutical or cosmetics industry. Machines, Tools, Equipment and Work Aids: PC, Word-processing and spreadsheet software, Calculator, Federal Register, Rose Sheets, CTFA, Technical Regulator Notes, Cosmetic Ingredient Review, USP/NF, other standard laboratory and office equipment. License(s)/Certification(s) Required: Certification in Quality Assurance preferred.