Specialist Quality

POSITION SUMMARY: Coordinates the documentation process for stability of product formulation. Coordinates the pulling of product samples and enters data into calendar schedules. Maintains all necessary records; writes protocols/specifications, final reports as needed; interacts with all levels of manufacturing and production process.

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.

1. Attendance: Present for work when scheduled is a mandatory function.
2. Safety: Your compliance with all company safety rules, procedures, and guidelines are essential.

4. Develop, implement, and maintain stability documentation standards.

1. Applies basic knowledge of methods, specifications, and attributes to be tested (chemical, micro), manufacturing changes, and container/closure changes to maintain control of stability testing and documentation procedures.
2. Provide technical assistance and interface with other departments in connection with stability requirements.
3. Assists Research & Development with OOS investigating, signs off on documentation.
4. Generates reports and keeps others informed of current processes and status of stability testing and expiration dating.
5. Assists with GMP required documentation and compliance with governmental regulations such as FDA, EPA, and ATF.
6. Interact regularly with various phases of manufacturing, including Sourcing, QC, QA, R & D, Production, and Contract Manufacturing.
7. As requested check documents for compliance with state and federal law; verify accuracy.
8. Access, input and retrieve information from the computer system.
9. Weekly monitoring of Environmental Chambers.
10. Coordinate maintenance schedule for Chambers.

Marginal Functions:

1. Perform regression analysis.

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 eye to bring objects into sharper focus.

Environmental/Atmospheric Conditions: Worker exposed to typical office conditions, and some plant conditions. Occasionally exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort and exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level.

POSITION QUALIFICATION REQUIREMENTS:

Knowledge: Requires a BA/BS degree, with a Chemistry background. Requires knowledge of laboratory procedures including methods, specifications, and attributes to be tested, manufacturing changes, container/closure changes, etc. Must have knowledge of PC and business application software, BS/BA preferably in chemistry. Must possess attention to detail and written communication skills.

Experience: Requires 1-year experience in a pharmaceutical or health and beauty environment, with exposure t laboratory testing and documentation procedures. Experience in regression analysis is also desirable.

Machines, Tools, Equipment and Work Aids: Computer; database, word processor, pH meter, viscometer, balance, hydrometers, Federal Register, CFR, FDA stability guidelines.

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