MQA Specialist II

Amneal

About The Position

The MQA Specialist II performs inspection, sampling, and testing, where applicable, of incoming materials, packaging components, and returned goods according to written procedures. The role supports the flow and testing of raw and critical materials through follow-up with internal and external laboratories, cleans and sanitizes ISO 7 areas and ISO 5 laminar flow hoods, assigns and verifies GMP raw-material expiry and retest dates, and reviews and releases raw and critical materials. The position reviews documentation for batch, laboratory, warehouse, metrology, engineering, validation, and quality-event activities to ensure completeness and compliance with company procedures and cGMP requirements. It supports the facility quality-event system, checks cross-references and batch-documentation inclusion, conducts quality-assurance walkthrough audits of manufacturing, laboratory, and warehouse areas, and contributes to projects addressing quality and manufacturing issues and corrective and preventive actions. The specialist also provides backup for other Quality Assurance Specialist responsibilities and performs other duties as delegated by Quality Management. The schedule is Monday through Friday, 8:30 a.m. to 5:00 p.m., with possible weekends as needed. Flexible hours may be required. The general work environment and physical demands are those needed to perform the job's essential functions; the employee must be able to work under pressure and meet deadlines.

Requirements

A four-year bachelor's degree; a science or engineering discipline is preferred.
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, within the department and cross-functionally.
Ability to organize, plan, and manage assigned tasks through completion.
Strong written and verbal communication skills.
Excellent organizational skills and attention to detail.
Excellent time-management skills and ability to prioritize assignments effectively.
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 documents that are clear, concise, accurate, and complete.
Ability to work flexible hours as needed and under pressure while meeting deadlines.

Nice To Haves

A bachelor's degree in a science or engineering discipline.

Responsibilities

Inspect, sample, and test incoming materials, packaging components, and returned goods where applicable, following written procedures.
Follow up with internal and external laboratories to support the flow and testing of raw and critical materials.
Clean and sanitize ISO 7 areas and ISO 5 laminar flow hoods 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 documentation supporting quality-event investigations, including change controls, deviations, out-of-specifications, and complaints, before final disposition.
Assist with quality-assurance procedures governing 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 walkthrough 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 corrective and preventive actions in a timely manner.
Assist with projects supporting the needs of Quality Management.
Perform other duties and responsibilities as delegated by Quality Management.