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Quality Assurance Specialist
Rensselaer, NY Rensselaer, NY, US 12144
Date Needed By
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.
# of Hires Needed
BS preferably in Chemistry with 2 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 meettimelines
Ability to manage multiple projects
Work collaboratively, act decisively and have passion for internal customers
Communicate and coordinate effectively with other departments.