Senior Quality Management System Specialist

About the Organization
AAA Pharmaceutical is a manufacturer of Over-the-Counter pharmaceuticals.

Position
Senior Quality Management System Specialist

Category
Quality Assurance

Description


Company Description:

AAA Pharmaceutical Inc. is an established and respected over-the-counter pharmaceutical company that has been a trusted leader in the industry for the past three decades. Located in Southern New Jersey (Lumberton and Paulsboro), we have a strong commitment to manufacturing, packaging, and distributing high-quality oral solid-dosage formulations as well as maintaining our trusted reputation for producing drug products that are on par with the therapeutic performance of national brands.

AAA Pharmaceutical understands the importance of affordability and aims to provide cost-effective solutions to its partners and customers. By prioritizing quality, the company ensures that its products consistently meet the highest standards, instilling trust and confidence in both customers and consumers. With a focus on values such as teamwork, ethics, and excellence, AAA Pharmaceutical Inc. continues to foster strong partnerships and drive sales growth for its partners.

AAA Pharmaceutical Inc. is an established and respected over-the counter (OTC) pharmaceutical company that has been a trusted leader in the industry for the past three decades. Located in Southern New Jersey (Lumberton and Paulsboro), we have a string commitment to manufacturing, packaging, and distributing high quality oral solid dose (OSD) formulations as well as maintaining our trusted reputation for producing drug products that are on par with the therapeutic performance of national brands.

AAA Pharmaceuticals understands the importance of affordability and aims to provide cost-effective solutions to its partners and customers, By prioritizing quality, the company ensures that its products consistently meet the highest standards, instilling trust and confidence in the both customers and consumers, With a focus on values such as teamwork, ethics and excellence AAA Pharmaceutical Inc. continues to foster strong partnerships and drive sales growth for its partners.
Role Description

This is a full-time Quality Management System (QMS) role at AAA Pharmaceutical, Inc. As a Senior Specialist, you will be responsible for ensuring compliance with quality standards and regulatory requirements. You will help design, modify, implement, and maintain QMS, including documentation and the auditing processes. You would also be responsible for supporting manufacturing, packaging, warehousing, laboratory operations, and others within the Quality Unit while ensuring that the product meets GMPs, are of high quality, and meet the customer requirements.

Requirements

The requirements of this role include:

1. Having a minimum of five (5) years of experience in the pharmaceutical industry.
2. Preference will be given to candidates who have experience at either generic or OTC firms.
3. Additionally, experience in OSD is preferred
   1. In either Manufacturing Operations (blending, compression, etc.) or
   2. Packaging Operations (bottles, blisters, cartons, etc.).
   3. Experience in both areas is a plus.
4. Writing and/or reviewing QMS documents (deviations, change controls, CAPAs, other quality events etc.)
5. Identifying deficiencies and proposing overall compliance improvements.
6. Possessing a high level of attention to detail
7. Knowledge of regulatory requirements.
8. The ability to work independently and collaboratively in a team environment.
9. Initiates, investigates, and documents deviations and other quality events.
10. Performs root cause analysis.
11. Develops, in conjunction with area management, effective corrections, corrective actions, and preventive actions.
12. Initiates, investigates, and closes customer complaints.
13. Ensures customer complaint data is tracked for trend review, annual product review and management reviews.
14. Assists with the Vendor Management Program including Quality Agreement
15. Completes Annual Product Reviews (APRs)
16. Writes and reviews documentation (quality events, standard operating procedures, work instructions, stability protocols, change controls, etc.).
17. Reviews and confirms the content of artwork.
18. Reviews and approves packaging specifications and master label cards (for labels and individual folding cartons)
19. Completes periodic review of applicable documents within the required time limit.
20. Overall responsibility for stability program. Ensures stability samples are placed on stability and evaluated according to approved protocols.
21. Fulfills requests for quality documentation from customers, including maintenance of our information on customer quality portals
22. Maintains and improves the level of compliance of cGMP and maintains an understanding of FDA regulatory expectations, initiatives, and requirements.
23. Provides regular reports detailing the status of open quality events.
24. Identifies and helps to remediate non conformances.
25. Supporting the overall company GMP training program and conducting training for changes to policies and procedures
26. Maintaining applicable quality databases and ensuring they are current and accurate.
27. Supports ongoing quality improvement initiatives.
28. Assists in maintaining an inspection readiness state.
29. Supports the Director of Quality during audits and inspections
30. Support company improvement and growth initiatives.
31. Perform other duties as assigned

Location
Lumberton

Position Requirements

Qualifications

• B.S in science required.
• Minimum five (5) years of experience in the pharmaceutical industry
• Experience working in or interfacing with pharmaceutical manufacturing, packaging, warehouse, laboratory, and quality departments.
• A thorough understanding of Quality Management Systems is required.
• Experience with an electronic QMS system is a plus.
• Experience interfacing with external vendors.
• Previous experience with customer complaints and completing APRs is required.
• Strong knowledge and understanding of GMP regulations and QMS Systems.
• Well versed with the expectations of the FDA.
• Strong interpersonal skills; ability to communicate effectively with individuals and groups; ability to communicate ideas clearly with technical and non-technical colleagues.
• Ability to manage diverse tasks and issues simultaneously through prioritization, delegation, and "hands-on" personal effort.
• Self- starter with effective interpersonal and organizational skills.
• Well versed in using MS Office
• Ability to learn new software/applications.
• Ability to write well.
• Ability to participate in a team environment with demonstration of a shared responsibility for outcomes.

.Physical Requirements

• Ability to travel as needed.
• Ability to lift 25-50lbs. relating to incoming materials, supplies.

PAY RANGE 75k to 88k

Full-Time/Part-Time
Full-Time

Shift
Days

Pay Rate
75k to 88k

EOE Statement
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

Exempt/Non-Exempt
Exempt

Req Number
QUA-26-00001


This position is currently accepting applications.