MQA Specialist II

Amneal•Piscataway, NJ

3d•$75,000 - $90,000

About The Position

The MQA Specialist II performs quality assurance activities for incoming materials, manufacturing, laboratory, warehouse, and quality event processes in a cGMP pharmaceutical manufacturing environment. The role inspects, samples, and tests incoming materials, packaging components, and returned goods; coordinates critical material testing; assigns and verifies GMP raw material expiry and retest dates; and reviews and releases raw and critical materials. The specialist reviews documentation for batch, laboratory, warehouse, metrology, engineering, validation, and quality event activities to ensure completeness and compliance with company procedures and cGMP requirements. The role also conducts quality assurance walk-through audits, supports investigations and corrective and preventive actions, contributes to projects addressing quality and manufacturing issues, and provides backup for other Quality Assurance Specialist responsibilities. The schedule is Monday through Friday, 8:30 a.m. to 5 p.m., with possible weekends as needed. Flexible hours may be required.

Requirements

Four-year bachelor's degree, preferably in a science or engineering discipline.
2–5 years of quality assurance experience in a cGMP pharmaceutical manufacturing environment.
Working knowledge of cGMP regulations, including 21 CFR 210/211.
Ability to work independently and in teams, including cross-functional teams.
Ability to organize, plan, and manage assigned tasks through completion.
Strong written and verbal communication skills.
Excellent organizational, detail-orientation, and time-management skills, including the ability to prioritize assignments.
Ability to coordinate projects and activities with other quality assurance staff.
Excellent computer skills in Microsoft Office applications.
Experience authoring technical reports and creating templates.
Ability to use technical information to produce clear, concise, accurate, and complete documents.
Ability to work flexible hours as needed and under pressure to meet deadlines.

Responsibilities

Inspect, sample, and test incoming materials, packaging components, and returned goods in accordance with written procedures.
Follow up with internal and external laboratories to support the timely flow and testing of raw and critical materials.
Clean and sanitize the ISO 7 area and ISO 5 laminar flow hood according to written procedures.
Assign and verify expiry and retest dates for GMP raw materials using vendor and/or in-house certificates of analysis.
Review and release raw materials and critical materials.
Review documentation for batch, laboratory, warehouse, metrology, engineering, and validation activities for completeness and compliance with company policies, procedures, and cGMP requirements.
Review quality event investigation documentation, including change controls, deviations, out-of-specification events, and complaints, before final disposition.
Assist with quality assurance procedures for the facility quality event system and support compliance with cGMP regulations, customer expectations, and company policies.
Ensure quality events are appropriately cross-referenced and completed events are included in batch documentation before final disposition.
Conduct quality assurance walk-through audits of manufacturing, laboratory, and warehouse areas.
Provide backup for other Quality Assurance Specialist responsibilities.
Contribute to project teams addressing quality and manufacturing issues and identifying and implementing timely corrective and preventive actions.
Assist with projects supporting the needs of Quality Management.
Perform other duties and responsibilities delegated by Quality Management.