Compounder (Level 3)

JOB SUMMARY

This Compounder level familiarizes an employee with the actual manufacture of Blistex products and adherence of proper GMPs in accordance with FDA and OSHA guidelines. A Compounder (Level 3) must be able to manufacture all of the simple blends of Blistex products in addition to ointments and creams before being considered for promotion to the next Compounder level. The Compounder (Level 3) is an Hourly position.

ESSENTIAL JOB FUNCTIONS

1. Set-Up (Preparation)

2. Checks items per batch sheet

3. Ensures that all chemicals and the proper amounts of chemicals are available.

4. Utilizes the FIFO method for issuing chemicals to a batch.

5. Uses the proper in-process forms [e.g., product, item, temperature, mixing speed, change in codes, or new items].

6. Uses the proper documentation, double checks, and signs off on all Quality Assurance paperwork and Line Release papers.

7. Uses the assigned lot code sequence for product families and properly issues product to the Product Order.

8. Ensures proper equipment set-ups (e.g., temperature, speed, mixing speed, and timings for each step per the batch sheet).

9. Conducts sanitization of equipment according to the equipment log sheets.

10. Set-Up (Quality Checks)

11. Ensures that the chemicals have the proper release sticker and that the expiration date has not passed or it has been retested.

12. Ensures the quality of the physical properties of our products and finished products (e.g., no foreign matter, color is within specification, no un-melted wax, aerated product, or in-consistent viscosity).

13. Transfers product to holding tank and maintains the proper temperature or cooling of product for ambient product.

14. Performs scale checks.

15. Sets and fills hotboxes and records associated documentation.

16. Starts-up and shuts-down all air compressors.

17. Performs all checklist functions associated with the de-ionized water system.

18. Assists Research & Development personnel in the manufacture of pilot batches.

19. Uses the computer to evaluate chemical inventory control and batch sheet issuance, generates various computer reports; and, enters and retrieves data from the computer system, as required.

20. Disassembles, sanitizes and re-assembles all equipment used for the manufacture of Blistex products.

21. Reads, interprets and follows written product formulas to consistently create quality product batches.

22. Weighs and adds the ingredients for each batch of product according to the batch sheet.

23. Verifies information and ensures the proper initialing of FDA legal documents.

24. Completes and maintains accurate logbooks and any other forms associated with this position.

25. Sets up the correct products with associated equipment for product feed to the manufacturing lines.

26. Identifies and stages raw materials used in the manufacture of products and proper storage of raw chemicals after usage.

27. Cleans and sanitizes all equipment used in the manufacture of product, utilizing the CIP (cleaning in place) System.

28. Disposes all non-usable chemicals and products according to GMP regulations.

ADDITIONAL RESPONSIBILITIES

1. Performs and assumes other duties and responsibilities, as may be required by the Director, Manufacturing and/or Vice-President, Operations.

2. Participates in all physical inventory functions.

3. Maintains a clean work area and performs all housekeeping duties, as assigned.

4. Supports the Winner's Circle and Blistex Quality System processes.

REQUIRED EDUCATION, EXPERIENCE AND SKILLS

1. A high school diploma or equivalent.

2. The knowledge and skills required for this position are typically acquired in 3 to 4 years of practical work experience with production filling lines and with a batching process of blends in a pharmaceutical, cosmetic or food manufacturing environment.

3. Familiarity with batching process of blends, creams and lotions in a CGMP/FDA environment.

4. Must be able to convert pounds, ounces, kilos, grams and other liquid measurements.

5. Ability to occasionally provide leadership skills.

6. Must possess good mathematical aptitude (addition, subtraction, multiplication and division).

7. Must be able to operate a calculator.

8. Good oral and written communication skills in business English.

9. Considerable interpersonal skills are required to interact with internal customers.

10. Ability to follow written and verbal instructions.

11. Ability to learn and apply accrued knowledge of GMP, OSHA, FDA, SOPs, CFRs, CGMP, Hazmat and any other related guidelines or training associated with the job.

12. Computer literate in basic computer functions (e.g., data entry, inquiry, print, e-mail [Outlook], etc.).

13. Must be able to work with hazardous materials and comply with safety regulations.

14. Must be flexible to work 1st, 2nd, 3rd or a modified work shift, as departmental needs demand.

15. Must have prior experience operating a forklift.

16. Must be able to operate all equipment in the process of manufacturing and transferring all chemicals and Blistex products.

17. Ability to work independently and meet deadlines on a multitude of concurrent tasks, adhering to prescribed routines and practices.

18. Willingness to accept other duties, as assigned.

19. Must possess the ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from management and comply with Company policies.

SAFETY

1. Complies with all safety regulations.

2. Must wear protective ANSI-approved, chemical and slip resistant, safety shoes.

3. After receiving proper training in the care and usage of a respirator, a Compounder (Level 3) must wear a respirator in designated areas.

1st Shift:

7 AM - 3:30 PM