Quality Management System Specialist

1 week ago

Lumberton, United States AAA Pharmaceutical, Inc. Full time

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.

**Role Description**

This is a full-time Quality Management System (QMS) role at AAA Pharmaceutical Inc. As a Specialist or 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 laboratory operations, manufacturing, packaging, warehousing, and others within the Quality Unit while ensuring that the products meet GMPs, are of high quality, and meet customer requirements.

**Job Summar**y

The requirements of this role include:
1. Experience in the Pharmaceutical Industry with oral solid dose (OSD) is preferred [either Packaging (bottles, blisters, cartons, etc.) or Manufacturing Operations (blending, compression, etc.
2. Write and/or review Quality Management System Documents (deviations, change controls, CAPAs, etc.
3. Experience in quality management, quality control, and quality assurance.
4. Identifying deficiencies and proposing overall compliance improvements.
5. Strong analytical skills and attention to detail.
6. Excellent communication and interpersonal skills
7. Knowledge of regulatory requirements and industry standards
8. Ability to work independently and collaboratively in a team.

**Key Accountabilities Accountability**

Identifying and helping to remediate non conformances within laboratory operations, manufacturing, packaging, quality, and warehousing.
Initiating, supporting, reviewing, and completing manufacturing or packaging floor incidents, atypical material issues, and additional inspections, in a timely manner

Assisting with maintenance of documentation including forms, SOPs, work instructions, calibration documentation, change controls, specifications, batch records, etc.

Maintaining applicable quality databases and ensuring they are current and accurate.

Supporting ongoing quality improvement initiatives

Maintaining an inspection readiness state

Supporting Quality Director during audits and inspections Supervisory Activities:
Establishing goals in support of employee development and providing ongoing mentoring and coaching as a form of training and continuous improvement.

Planning and conducting regular QA team meetings. Maintaining records.

Providing timely, useful information and data to the Quality Director.

Interviewing, hiring, training, and developing all direct reports, ensuring employees can function effectively in a team-based, cooperative culture. Completing ongoing, documented performance evaluations, discipline as necessary, and annual performance reviews

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