Supervisor Quality Qc

POSITION SUMMARY:

Supervise all laboratory activities. Ensure compliance with all applicable regulatory requirements including FDA, laboratory methodology, and quality systems. Knowledge of EPA and OSHA requirements are helpful. Advise and monitor adherence to policies and procedures to improve operations and maintain compliance. Mentor and train associates on policy and procedures. Responsible for the supervision of staff and related activities. Must be versed in all routine duties of Analytical Laboratories. Coordinate information exchange within the company for all testing and approval functions. Coordinate and execute projects as assigned by the QC Manager.

FUNCTIONS OF THE JOB:

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. Function as a 'go-to' resource for any company associate on any topic. Be able to provide information or assist the associate in locating the proper resources or personnel.
5. Supervise daily functions of the microbiology and chemistry laboratories.
6. Ensure laboratory budget is met and maintained.
7. Perform final review of test data reports to ensure conformance to established specifications.
8. Review and/or develops specifications for new or changed components and products.
9. Conduct and/or review OOS investigations, propose corrective actions, trend OOS, ensure corrective actions are completed.
10. Coordinate installation, qualification, calibration, and maintenance of laboratory equipment.
11. Interact with production management daily and ensure the labs maintain a high level of efficiency and effectiveness.
12. Review technical reports, regulatory guidance, regulations, and other sources of information to ensure that lab practices and SOPs are consistent with industry and regulatory requirements.
13. Evaluate technical problems and provide recommendations for corrective actions.
14. Write, collect, organize, and compile data and reports to provide information for use by upper management or to comply with regulatory requirements.
15. Identify resource needs.
16. Develop appropriate training plans and ensure staff is trained in analytical techniques, cGLP, cGMP, and department SOP/QWIs.
17. Apply expertise in operation, maintenance, and troubleshooting of complex equipment. Ensure staff is trained in the same.
18. Perform general HR responsibilities including recruiting activities, performance evaluations, and progressing discipline.
19. Assure staff compliance to all SOPs/QWIs and regulatory requirements.
20. Identify process improvement opportunities, recommend solutions, and implement action plans.
21. Initiate and carry out appropriate self-development activities.
22. Perform other related duties as assigned.
23. Provide special laboratory testing as requested by: Sales, Research & Development, Purchasing, and customer complaints, etc.
24. Actively participate in all safety programs.
25. All other duties as assigned.

Physical Activities: Standing, walking, sitting, climbing stairs and ladders, typing, talking, and listening, identifying colors and ability to see.

Physical Demands: Occasionally lift boxes of product 5-40 lb. Frequently lift samples 1-5 lb.

Visual Acuity: Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust the eye to bring objects into sharper focus.

Environmental/Atmospheric Conditions: Worker 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 to be heard above the ambient noise level. Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line, and warehouse environments.

POSITION QUALIFICATION REQUIREMENTS:

Knowledge: BS in Chemistry or related science, MS preferred. Thorough understanding of FDA regulations, laboratory methodology and procedures, chemistry, quality systems and lab equipment. Must possess excellent written and oral communication skills. Extensive knowledge of cGMP requirements as they relate to laboratory functions. Knowledge of separation science, aspects of pharmaceutical analytical chemistry and applications of chromatography data systems. Knowledge of equipment calibrations and maintenance. Good understanding of experimental design and statistical applications is essential. MS Office Suite, SAP a plus.

Experience: Minimum 5 years of QC/QA experience in a regulated industry, in drug or cosmetic. Minimum of 1 year's supervisory experience. Demonstrated proficiency in a laboratory environment, time management, project development and prioritization are required. Demonstrated interpersonal skills are vital.

Machines, Tools, Equipment and Work Aids: Computer and related programs, versed in the safe, efficient use of all laboratory equipment and supplies. Written and on-line reference sources including USP/NF, FCC, ACS, CTFA and other publications and standard office equipment.

License(s)/Certification(s) Required: None identified.