Quality Assurance Specialist
AMRI - Rensselaer, NY

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Job Description
: Job Summary: Responsible for coordinating the receipt, testing requirements, and release of API, raw materials, and components used in GMP manufacturing. Provides Quality support for and interaction with Shipping, Receiving, Materials, QC Laboratories and Inventory control activities. Identifies, investigates, and resolves issues pertaining to incoming, quarantined, conditionally released, and approved materials; Review Material Specifications. Establishes and maintains cGMP procedures for incoming material specification requirements, sampling, storage, and release. Schedules and prioritizes work in accordance to production plans. Collaborate with other departments.

Support cGMP manufacturing material requirements, responsible for assuring acceptable materials released per material specifications

Lead the materials release team and maintain daily schedule

QA review and release of cGMP materials and components

Communicate and coordinate effectively with other departments

Write and maintain cGMP procedures.

Write and review material specifications.

Collaborate with QC to assure required testing is performed.

Collaborate with QA to assure that materials are appropriately qualified and tested per material specifications.

Perform investigations for nonconforming materials.

Maintain inspection ready procedures and participate in audits and inspections.

Maintain QC Sampling area.

Maintain Quarantine area.

Maintain appropriate labeling of incoming materials.

Work pro-actively on a daily basis to ensure schedules are maintained and material is readily available.

Manage conditionally released material disposition.

Assist with Materials release Weekly and Monthly metric reporting.

Identify continuous improvement efforts, including cost/expense control while maintaining GMP compliance.

Build quality into all aspect of the material release process by maintaining compliance to all quality requirements.

Job Requirements
: BS preferably in Chemistry with 5 years experience in a Quality role involving cGMP

materials, preferably in a pharmaceutical or medical device industry

Working knowledge of MRP principles and materials management is a must

Computer software knowledge (Microsoft Office)

High degree of initiative with demonstrated ability to work independently and meet


Ability to manage multiple projects

Work collaboratively, act decisively and have passion for internal customers

Communicate and coordinate effectively with other departments.

AMRI - 18 months ago - save job - copy to clipboard
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