Quality Assurance Specialist Ii

QUALITY ASSURANCE SPECIALIST II in Albany, NY
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Quality Assurance Specialist II is an integral part of the AMRI team, contributing to our success by performing activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, Company and customer quality standards as well as external regulatory requirements.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
In This Role, You Will

• Review and approve material release specifications, batch records and certificates of analysis.
• Assist with Regulatory and Customer audits as required.
• Author, review and approve SOPs.
• Assist in resolving quality problems/concerns with quality control and manufacturing personnel.
• Develop and maintain a thorough understanding of cGMPs and associated regulations. Apply this knowledge in the everyday work environment, providing consultation as necessary. Actively participate in resolving quality issues. Make suggestions for quality system improvements and recommend methods to increase the quality of products and/or services. Participate in the implementation of these improvements.
• Author and review change controls.
• Assist in internal audit programs as required.
• Track, review and approve training records and related Quality Documents.
• Disposition of final intermediates and APIs (includes review of all associated documentation).
• Author and review deviations and investigations. Compile data, prepare and review trends. Identify areas of concern and communicate to management.

Qualifications
Education and/or Experience:

• Requires BS/BA in scientific discipline or related field
• A minimum of five years GxP experience in an FDA-regulated pharmaceutical environment.

All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.