Quality Assurance Inspector Ii - 3Rd Shift

Hours: 10 pm - 6:30 am

ESSENTIAL JOB FUNCTIONS

1. Monitors line clearance functions.
2. Issue production paperwork and issues labels.
3. Draws and keeps records of samples from production lines for testing, retention, stability, and other purposes, as required or as necessary.
4. Acts as liaison between the Production and the Quality Department.
5. Performs yearly monitoring of retain samples.
6. Examines filling/packaging labeling before filling operation.
7. Master the ability to read, review and compare documents and follow procedures.
8. Solid understating of Batch documentation requirements and all associated production and compliance steps.
9. 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. Performs and assumes other duties and responsibilities, as may be required by the Manager, Quality Assurance.
5. Assists Manager, Quality Assurance with Auditing Program.
6. Assists with APR review.
7. Organizes and maintains samples of retain room within the retain room.
   

REQUIRED EDUCATION, EXPERIENCE AND SKILLS

1. High School Diploma or GED with 2-4 years of applicable Quality Assurance environment preferable in the cosmetics/pharmaceutical OTC industry
2. Bachelor's degree in Chemistry, Biology, or related scientific discipline with 0-1 years of applicable 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. Capable of effective communication skills for interactions with Quality Assurance colleagues, and colleagues from numerous functional areas.
7. Capable of listening actively and readily assumes responsibility for actions. Able to act as liaison between Production and Quality departments.
8. Master the ability to read, review and compare documents and follow procedures.
9. Solid understating of Batch documentation requirements and all associated production and compliance steps.
10. 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.)
11. Mastered the ability to prepare detailed and accurate documentation and able to proficiently search and issue documents via the organization QMS.
12. A firm understanding of general Quality Assurance practices and principles and cGMP requirements associated with the production and Quality life-cycle of a OTC drug.
13. Ability to understand "deals" and "PO" relationships associated with various markets.
14. Ability to understand the organization Stability program and sample retaining program.
15. Ability to accept projects as assigned.
16. Ability to execute projects under supervision.
17. Ability to understand and to perform calculations and measurements as required in SOPs.
18. Ability to understand the company nonconformance SOPs and assist with performing the investigations.
19. Understand Quality requirements and able to identify deficiencies during the product production process.
20. Effective interpersonal skills are required to interact with various levels of internal and external customers.
21. Ability to prepare detailed and accurate documentation.
22. Good organizational ability.
23. Must possess ability to work independently on a multitude of concurrent tasks.
24. Must be discreet with confidential information of which he/she has access.
25. 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.