Quality Assurance Inspector I

3rd shift: 10pm - 6:30am

JOB SUMMARY

The Quality Assurance Inspector I can have responsibilities in two areas: QA Receipt Inspection and QA Production Inspection. The position is responsible for sampling and inspecting incoming packaging and chemical raw materials for conformance to regulatory and Company standards. He/she ensures that everything required to complete a designated batch (raw materials, components, caps, bottles, and the packaging) is correct. The position is also responsible for the issuing of batch records and monitoring the quality of production.

ESSENTIAL JOB FUNCTIONS

1. Evaluates each receipt for conformance to purchase order requirements.

2. Verifies the integrity of shipping containers and ensures that each container is properly labeled.

3. Samples each receipt based upon a statistical sampling plan.

4. Inspects sampled items, following established Company specifications, by using visual evaluations and measurement devices that can include scales, rulers, micrometers, and calipers.

5. Document activities performed.

6. Maintains files of receipt inspection and vendor performance reports.

7. Performs computer transactions according to the Quality Systems receipt inspection process.

8. Assists in the development and maintenance of item specifications and master files.

9. Coordinates, in conjunction with the Purchasing Department, the set-up of standards with suppliers.

10. Ability to read, review and compare documents and follow procedures.

11. Monitors line clearance functions.

12. Issue production paperwork and issues labels.

13. Draws and keeps records of samples from production lines for testing, retention, stability, and other purposes, as required or as necessary.

14. Acts as liaison between the Production and the Quality Department.

15. Performs yearly monitoring of retain samples.

16. Examines filling/packaging labeling before filling operation.

17. Master the ability to read, review and compare documents and follow procedures.

18. Solid understating of Batch documentation requirements and all associated production and compliance steps.

19. Ability to understand and review all compliance steps associated with the production of OTC drugs (i.e., line clearances, filling/packaging labeling, production sampling requirements, and etc.).

ADDITIONAL RESPONSIBILITIES

1. Quarantine filling/packaging materials, brought to the production lines, if not in conformance with standard specifications/artwork or are found defective.

2. Quarantines finished products if found defective due to labeling, weight deficiencies, coding, etc.

3. Prepares “REJECT” stickers, if needed, for rejected filling/packaging materials, from the production lines.

4. Assists Manager, Quality Assurance with Auditing Program.

5. Assists with APR review.

6. Organizes and maintains samples of retain room within the retain room.

7. Performs and assumes duties and responsibilities, as may be required by the Senior Manager, Quality Assurance.

8. Supports the Winner’s Circle and Blistex Quality System processes.

REQUIRED EDUCATION, EXPERIENCE AND SKILLS

1. High School Diploma or GED required; additional education preferred.

2. The knowledge and skills required for this position are acquired with a minimum of 2 years of experience in a Quality Assurance environment preferable in the cosmetics/pharmaceutical OTC industry.

3. Computer literacy and experience.

4. Ability to multi-task and maintain precise organization in a fast-paced environment.

5. Ability to follow routine process without deviation.

6. Good listening skills to assure mutual understanding.

7. Can assume responsibility for actions and able to work independently and meet deadlines on a multitude of tasks.

8. Ability to read, review and compare documents and follow procedures.

9. Ability to prepare detailed and accurate documentation.

10. Ability to understand vendor documentation for components shelf-life.

11. Ability to support projects as assigned.

12. Ability to perform basic arithmetic and complete 2-D measurements.

13. Effective interpersonal skills are required to interact with various levels of internal and external customers.

14. Ability to work independently and meet deadlines on a multitude of tasks.

15. Good organizational ability.

16. High degree of familiarity with and ability to use office machines.

17. Must be discreet with confidential information of which he/she has access.

18. Capable of listening actively and readily assumes responsibility for actions. Able to act as liaison between Production and Quality departments.

19. Solid understating of Batch documentation requirements and all associated production and compliance steps.

20. Ability to understand and review all compliance steps associated with the production of OTC drugs (i.e., line clearances, filling/packaging labeling, production sampling requirements, etc.)

21. Mastered the ability to prepare detailed and accurate documentation and able to proficiently search and issue documents via the organization QMS.

22. A firm understanding of general quality assurance practices and principles and cGMP requirements associated with the roles and with the production and Quality life cycle of an OTC drug.

23. Ability to understand "deals" and "PO" relationships associated with various markets.

24. Ability to understand the organization Stability program and sample retaining program.

25. Ability to accept other duties and projects as assigned.

26. Ability to execute projects under supervision.

27. Ability to understand and to perform calculations and measurements as required in SOPs.

28. Ability to understand the company nonconformance SOPs and assist with performing the investigations.

29. Understand Quality requirements and able to identify deficiencies during the product production process.

30. 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.

PHYSICAL DEMANDS & ENVIRONMENT

1. This position requires the individual to Stand, Walk, use hands to finger, handle or feel, stoop, kneel, bend or crawl 33 to 66% of the time. This position requires the individual to Sit, climb or balance, reach with hands and arms overhead up to 33% of the time. This position requires the individual to Talk or Listen 66 to 100% of the time.

2. This position will require the individual to lift up to 25 pounds up to 33% of the time.

3. The vision requirements for this position includes Close Vision (clear vision at 20 inches or less), Distance Vision (clear vision of 20 feet or more), Color Vision (ability to identify and distinguish colors), Peripheral Vision (ability to see up, down, left or right while eyes are fixed on a given point), Depth Perception (3-dimensional vision, ability to judge distances and spatial relationships), and Ability to Adjust Focus (ability to adjust the eye to bring an object into sharp focus).

4. This position has exposure to wet, humid conditions (non-weather), work near moving mechanical parts or vibration up to 33% of the time.

5. The noise level for this position will be Moderate Noise (Ex: Business office with typewriters and/or computer printers, light foot traffic).

6. The Personal Protective Equipment requirements that are used in this position is a hair net, beard net, safety glasses, and cut resistant gloves.

3rd Shift - 10pm - 6:30am

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