Quality Assurance Specialist

Quality Assurance Specialist

The Quality Assurance Specialist provides expertise to the Quality Department in one or more specialized areas. The Quality Assurance Specialist is responsible for performing investigations, completing Investigation Reports (IRs), tracking Corrective Action Preventive Action (CAPA), administering the product stability program, conducting current Good Manufacturing Practices (cGMP) training, maintaining a training record system, assisting with the Quality Management Software, acting as a liaison with chemical suppliers, and performing cGMP compliance audits.

Essential Job Functions

1. Performs investigations of non-conformance including customer and consumer complaints and tracks resulting CAPA action plans.
2. Conducts cGMP training and maintains training records.
3. Administers the product stability program and designs compliant bracketing and matrix strategies for stability profiles.
4. Administers the cGMP compliance audit program.
5. Develops and maintains SOPs and forms governing areas of responsibility.
6. Acts as a liaison with raw material manufacturers and suppliers ensuring compliance with Blistex and regulatory requirements.
7. Assists Manager, Quality Assurance in administering the Quality Management Software.
8. Monitors regulatory and industry trends/actions and reports regularly to Quality management.
9. Develops and maintains performance measurements for areas of responsibility.
10. Master the ability to perform all associated Quality Assurance tasks to support and oversee Quality during Production, labeling and warehouse activities.
11. Solid working knowledge for performing investigation of non-conformance including consumer complaints investigation.
12. SME of cGMP requirements for an OTC drug manufacturing and able to apply the knowledge in daily tasks.

Additional Responsibilities

1. Performs and assumes other duties and responsibilities, as may be required by the Manager, Quality Assurance and/or Director, Quality.
2. Supports the Winner's Circle Process and Blistex Quality System.

Required Education, Experience and Skills

1. Bachelor's degree in Chemistry, Biology, or related scientific discipline with 3-5 years of applicable Quality Assurance environment preferable in the pharmaceutical OTC industry.
2. Master's degree in Chemistry, Biology, or related scientific discipline with 1-3 years of applicable Quality Assurance environment preferable in the pharmaceutical OTC industry.
3. Proficient at effective communication skills for interactions with Quality colleagues, project managers, and colleagues from numerous functional areas.
4. Proficient at listening actively and readily assumes responsibility for actions.
5. Leads by example.
6. Proficient at managing tactical steps to push task forward.
7. Demonstrates high standards of ethics and compliance.
8. Creates culture of mutual trust and understanding.
9. Master the ability to perform all associated Quality Assurance tasks to support and oversee Quality during Production, labeling and warehouse activities.
10. Solid working knowledge for performing investigation of non-conformance including consumer complaints investigation.
11. SME of cGMP requirements for an OTC drug manufacturing and able to apply the knowledge in daily tasks.
12. Master the understanding of the organization QMS for retrieval requirements, retrieve essential records, following record keeping procedures.
13. Solid ability to detect errors in production documents reviews, deviations files, all quality documents support product release.
14. Mastered ability to perform and document thorough quality investigations.
15. Mastered comprehensive understanding of cGMP regulations, SOPs, Quality Assurance procedures, auditing programs.
16. Solid working ability to identify trends and/or patterns during non-conformances, deviation, stability, testing, and product review investigations.
17. Master and manage the Stability program. Master the ability to identify trends in the data and react accordingly. Keep up with current Global ICH guidelines.
18. Master ability to handle multiple projects in logical sequence. Master ability to plan, organize and complete projects independently. Master keeping projects on target and on time with little to no delays.
19. 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. Solid understanding of how to review data for calculation errors and how to interpret data under supervision. Use data analysis and trends to assist in writing deviations, non-conformances, and investigational reports. Able to use statistical tool to analyze CAPAs effectiveness.
20. Mastered the requirements of the company nonconformance SOPs and perform the investigations. SME of the understanding of Quality and Compliance requirements.
21. Responsible for identifying deficiencies in Quality and Production documentation. Mastered working ability to complete sound, compliant, and thorough investigation and/or deviation.
22. Ability to propose effective CAPAs to investigation and/or deviation.
23. Effective interpersonal skills to interact with various levels of internal and external customers and suppliers.
24. Establishes priorities and works independently on a multitude of concurrent tasks with little supervision.
25. Detail-oriented and prepares comprehensive and accurate documentation.
26. Accepts other duties, as assigned.
27. Discreet with confidential information to which he/she has access.
28. Develops and maintains effective working relationships with internal and external customers and suppliers, functions as a team player, accepts constructive criticism from management, and complies with Company policies.

1st Shift 7 AM - 3:30 PM