QMS Associate

Job Description

Department

Quality Assurance

Job Title

QA Associate QMS

FLSA Status

Exempt

1. Role Purpose:

The QA Associate ensures quality and compliance of the facility with applicable regulatory requirements. These activities may include reviewing documents and data, conducting systems or process-focused audits and inspections, consulting on quality and compliance issues, maintaining quality databases, performing trend analyses and reporting metrics where required, as well as performing quality / compliance training, as needed. Provide support during regulatory inspections. Assists with the development of SOPs, specifications, and other quality document control activities as needed.

2. Key Duties & Responsibilities:

Conduct routine walk-throughs of manufacturing areas for adherence with SOPs and good documentation practices including but not limited to sample management and accountability, data integrity (manufacturing, calibration and maintenance logbooks, batch record documentation) and adherence with applicable safety requirements. Review documentation, results and reports from raw material and finished product analysis for accuracy and completeness.

Perform regularly scheduled, formalized internal audits of manufacturing areas for adherence with SOPs, cGMPs, FDA, OSHA, EPA and DEA regulations.

Review SOPs, Specifications, Batch Record Documentation.

Maintain KPIs related to manufacturing accuracy and conformance with SOPs, regulations and Guidelines and present to the Quality Council.

Review and maintain Quality Management Records (Change control, Deviation, CAPA, Root cause Investigations, Market complaints, Product recall, OOS and Outliers) to ensure compliance with procedures and assurance of due date requirements.

Review validation reports for aseptic manufacturing, filling and support processes, equipment, and utilities for compliance against approved protocols.

Ensure manufacturing compliance for adherence with aseptic technique, process validations, hold time studies, and media fill simulation studies.

Preparation and review of Standard Operating Procedures

Review executed documents for adherence with batch record, SOPs and protocol requirements.

Perform quality on-floor audits, area inspections, room and line clearances.

Assists with quality improvement initiatives as needed.

Assists with development/ writing of SOPs or other quality documents and/or reports as needed.

Provides consultation on quality and compliance topics in areas of expertise.

Performs other duties as assigned.

Complies with company polices, SOPs, and data integrity requirements.

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

Education Requirement

Specialization (If any)

Associates Degree/Certification/Diploma in a laboratory science, or a B.S. / BSc / B.A. degree preferred

Experience Requirement

N/A

Number of Years

1-3 years

5. Technical competencies/ Certifications/ Licenses:

Technical competencies

Ability to read, identify, transcribe, and communicate details accurately.

Ability to perform daily work assignments accurately, timely and in a safe manner with moderate supervision.

Must be able to multi-task and work in a fast-paced environment.

Self-motivated & exceptional organizational skills.

Ability and willingness to work cooperatively with others.

Knowledge of Microsoft Office products (Word, Excel) .

High degree of discretion dealing with confidential information.

Prior experience with electronic quality systems is preferred.

Manage time effectively to complete assignments in expected period.

Ability to communicate effectively and follow detailed written and verbal instruction.

Ability to train on SOPs, regulatory guidelines, and storage requirements.

Certifications

N/A

Licenses

N/A

Other

N/A

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A