Manager Quality Qc

POSITION SUMMARY: Manage all aspects of the Analytical Quality Control Function. Ensure compliance with all applicable regulatory requirements including FDA, EPA, DNR, BATF, and OSHA. Advise, instruct, develop, and implement policies and procedures to improve operations and maintain compliance. Mentors and trains associates on policies and procedures. Responsible for overseeing and supervision of staff and related activities. Must be versed in all routine duties of analytical QC staff (Chemistry & Raw Materials).

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: Compliance with all company safety rules, procedures, and guidelines is essential.
4. Develops, implements, and maintains quality specifications and standards for all raw materials, bulk and finished goods.
5. Performs testing on all samples submitted for analysis, including stability, method development, and R&D support.
6. Plans and forecasts for departmental staffing needs. Interviews job applicants, recommend qualified candidates for employment.
7. Trains and mentors QC personnel. Assigns work tasks to lab members to ensure an efficient QC function.
8. Provides on-going supervision and career development path to QC personnel. Conducts performance evaluations, assists employees in resolution of work related problems. Provides coaching and leadership to all personnel.
9. Provides technical assistance and interface with other departments to improve efficiencies, work flow, and cut costs. Communicates effectively throughout the organization to ensure quality issues are addressed.
10. Reviews customer complaints and works with other departments to address customer concerns.
11. Develops and validates new methods and procedures. Communicates new procedures to others and ensures adequate training is conducted.
12. Advocates GMP & GLP regulations and insures that all laboratory activities and documentation meet compliance standards.
13. Ensure compliance with all applicable regulatory requirements including FDA, EPA, DNR, BATF, and OSHA.
14. Actively participates in all safety programs.
15. Coordinate and approve all OOS & incident investigations, deviations, and NCRs.
16. Reviews and revises all laboratory policies, procedures, test methods, and job descriptions
17. Actively participates in cross functional teams to ensure quality standards are met.
18. Coordinates with QC staff to provide support to ensure raw materials, bulk and finished product meet OTC release timing.
19. Ensures all instruments and laboratory equipment are performing within calibration and adequately maintained to meet GMP & GLP regulations.
20. Understands and participates in change control process.
21. Creates and maintains budget and lab supplies.

Physical Activities: Walking, talking, hearing, climbing, balancing, reaching, grasping, standing, and stooping.

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 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 in order 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: Requires a bachelor's degree in chemistry or related scientific discipline and a thorough understanding of FDA regulations. Also requires a thorough working knowledge of laboratory methodology and procedures, chemistry, quality systems, and lab equipment. Must possess excellent written and oral communication skills. Must demonstrate a working knowledge of chemical analysis and laboratory bench work. Must possess an understanding of chemistry related math skills. Must have a working knowledge of computer usage including experience and ability to troubleshoot in SAP, spreadsheets, word processing, and database packages

Experience: Minimum of 7 years QC/QA experience in a regulated industry, preferable food, drug, or cosmetic. Minimum of 3 years leadership experience. Demonstrated proficiency in a laboratory environment, time management, project development and prioritization is required. Demonstrated interpersonal skills are vital. Experience in wet chemistry operations, operation of GC, HPLC, UV-VIS, IR, AA, and other laboratory instrumentation, including troubleshooting, maintenance, and repair. Must have thorough knowledge of laboratory operations with a high level of analytical problem solving skills.

NON-TECHNICAL SKILLS: 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 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. Must be able to track projects and ensure deadlines are met. Has a professional, helpful attitude accepts constructive criticism well, and is a team player. Serves as a mentor and provides leadership to QC chemists, analysts, and technicians. Must be familiar with written and on-line reference sources including USP/NF, FCC, ACS, CTFA and other publications.

Machines, Tools, Equipment and Work Aids:

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