Quality Assurance Specialist I - Document Control in Albany, NY
AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Quality Assurance Specialist is an integral part of the AMRI team, contributing to our success by ensuring the integrity of Quality Assurance Documents and assisting Quality Assurance Unit in maintaining Quality Systems in accordance with FDA regulations.
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:
- Responsible for retention, archiving and maintenance of all quality documents for the Quality Assurance Department.
- Responsible for coordinating new hire training and maintaining all training records.
- Responsible for tracking scheduled revisions of Standard Operating Procedures, preparing and issuing SOPs.
- Responsible for issuing controlled quality documents to laboratory personnel.
- Support QA during quality system audits and third party inspections.
- Assist and support and compile data for various quality system reports, presentations and or global compliance needs.
- Assist and maintain files such as Internal Audit, CAPA, Vendor Assessment and Monitoring files.
- Assist with tracking attendance, taking and storing meeting minutes, and scheduling follow-up meetings as needed for QA staff.
Qualifications and background to be successful in this role:
- Bachelors' degree required in Science or Technical Writing
- Must have prior QA experience in a regulated facility.
- A comprehensive understanding and working knowledge of the cGMP's is a preferred.
- Strong computer, document review, and organizational skills; Proficient in IT applications such as MS Word, Excel, PowerPoint, Access.
3 years' experience in GMP environment; Aseptic technique/manufacturing experience strongly preferred
- Strong familiarity with the regulatory requirements of 21CFR210 and 211
- Focused self-starter with attention to detail; team-oriented but able to work independently and proactively, and ability to multi-task
- Strong problem solving and organizational skills
- Experience working in a clean room with a thorough understanding of clean room personnel and material flows a must
All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.