Address
Form of workJob Description
JOB SUMMARY
The Coordinator is responsible for performing duties and assisting the Manager, Quality Assurance with product disposition functions, encompassing the review of production batch records and the associated documentation required to release a production lot. He/she ensures compliance to product specification, good documentation practices, data entry, completeness of COAs, Company SOPs and cGMPs reviewing all documents from Production, Quality Control Laboratory, Quality Assurance and/or other related documents to a batch. The completed production batch (finished product) does not release from the building without the incumbent’s approval to prevent distribution of non-conforming products to customers. A similar release process is followed with the review of the raw materials sampling, testing, approve and/or reject activities.
ESSENTIAL JOB FUNCTIONS
1. Coordinates the assembly of batch information generated by Quality Assurance, Production, Manufacturing and Quality Control Departments.
2. Reviews and audits batch records. Collects data for trending performance measurements.
3. Reviews and approves analytic and microbiologic reports and testing documents for raw materials, finished products, and stability studies.
4. Makes final decision on product release, in absence of discrepancies.
5. Coordinate correction of documentation errors with appropriate department(s); and notifies management of batch record errors.
6. Notifies management of discrepancies and documentation errors with batch records.
7. Verifies counts of finished products prior to release. Notifies production of count discrepancies.
8. Prepares release or quarantine notices/stickers for in-process batches and finished products.
9. Maintains the quarantine hold area.
10. Performs transactions in Adage system.
11. Troubleshoots quality issues and initiates non-conformance investigations and deviations, as needed.
12. Collects information for investigations of quality issues.
13. Maintains all in process batch files. Archives all completed batch records.
14. Provides customers with Certificates of Compliance and Certificates of Analysis when necessary.
15. Proficient at reading, reviewing, and auditing documents and follow procedures.
16. Mastered the understating of Batch documentation requirements and all associated production and compliance steps.
17. Proficient at understanding, reviewing, and auditing all compliance steps associated with the production of OTC drugs (i.e., line clearances, filling/packaging labeling, production sampling requirements, batch records, deviations, non-conformances etc.)
ADDITIONAL RESPONSIBILITIES
- Participates in cGMP compliance audits and other committees, as required by the Manager, Quality Assurance.
- Performs and assumes other duties and responsibilities, as may be required by the Manager, Quality Assurance (e.g. serves as back-up to Inspector, Quality Assurance and Inspector, Receipt).
- Supports the Winner’s Circle and Blistex Quality processes.
REQUIRED EDUCATION, EXPERIENCE AND SKILLS
1. High School Diploma or GED with 4-6 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 2-3 years of applicable Quality Assurance environment preferable in the cosmetics/pharmaceutical OTC industry.
3. Must demonstrate effective communication skills for interactions with Quality colleagues, and colleagues from numerous functional areas.
4. Must listen actively and readily assumes responsibility for actions. Capable of managing tactical steps to push tasks forward.
5. Proficient at reading, reviewing, and auditing documents and follow procedures.
6. Must possess a comprehensive understanding of CGMP/GLP regulations as they relate to the testing and reviewing of cosmetics and pharmaceuticals.
7. Mastered the understating of Batch documentation requirements and all associated production and compliance steps.
8. Proficient at understanding, reviewing, and auditing all compliance steps associated with the production of OTC drugs (i.e., line clearances, filling/packaging labeling, production sampling requirements, batch records, deviations, non-conformances etc.)
9. Firm understanding of the organization QMS for retrieval requirements, retrieve essential records, following record keeping procedures.
10. Solid ability to detect errors in production documents reviews, deviations files, all quality documents support product release.
11. Master the understanding of "deals" associated with various markets and the cGMP requirements associated with the production and Quality life-cycle of a OTC drug.
12. Solid understanding of technical requirements for all quality documentation supporting batch production documents and their lifecycle.
13. Firm understanding of the Stability program/schedule and the compliance requirements associated with them.
14. Firm understanding of the departmental compliance role and responsibilities.
15. Master the ability to plan, organize and complete concurrent tactical tasks independently.
16. Ability to plan, organize and complete strategic Departmental tasks independently.
17. Firm understanding of the calculations as required in Production and Quality Assurance SOPs and in performing basic statistical calculations related to % Difference, Average, Standard Deviation, % RSD.
18. Understanding of how to review data for calculation errors and how to interpret data under supervision.
19. Assist in writing deviations, non-conformances, and investigational reports.
20. Firm understanding of the company nonconformance SOPs and assist with performing the investigations.
21. Firm understanding of Quality and Compliance requirements while mastering the ability to identify deficiencies in Quality and Production documentation.
22. Ability to understand the requirements of a good investigation and/or deviation.
23. Considerable interpersonal skills are required to interact with various levels of internal and external customers.
24. Must possess the ability to prepare detailed and accurate documentation.
25. Good organizational ability and detail minded.
26. Must possess ability to work independently on a multitude of concurrent tasks.
27. Must be discreet with confidential information of which he/she has access.
28. Must possess high degree of familiarity with and ability to use office machines.
PHYSICAL DEMANDS & ENVIRONMENT
1. This position requires the individual to Stand, Walk, Sit, use hands to finger, handle or feel, and stoop, kneel, bend or crawl 33 to 66% of the time. This position requires the individual to Talk or Listen 66 to 100% of the time. This position requires the individual to climb or balance, reach with hands and arms overhead, and taste or smell up to 33% of the time.
2. This position will require the individual to lift up to 25 pounds to 33 to 66% 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.
