What are the responsibilities and job description for the Quality Assurance Specialist I position at Careers|CURIA?
Quality Assurance Specialist I in Albany, NY
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Quality Assurance (QA) Specialist I is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to manufacturing operations. This position’s role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action such that a) adherence to cGMPs and internal procedures/policies are maintained, and b) appropriate immediate corrective action is implemented and effectively documented in order to provide traceability and substantiation of any claims to be made in the investigation. This position primarily works in the cGMP production areas to manage adherence to the quality system and to initiate and assist in the initiation and resolution of deviations.
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.
Responsibilities
- Maintain Quality databases and scanning of cGMP documents and records, Departures, media fill programs, and training files
- Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented
- Solicit feedback from various departments for operational improvement
- Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc.
- Assist in performing investigations
- Perform and/or assist with internal audits, weekly walkthroughs, and/or external audits
- Perform QA visual inspection activities associated with clinical and commercial drug product
- With supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues
- Develop and/or maintain Quality System metrics for management review
- Assist in tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs
Required Qualification
- BS/BA in scientific discipline or related field
Preferred Qualification
- Experience in a cGMP and FDA-regulated industry
Knowledge, skills and abilities
- Excellent verbal and written communication skills
- Focused self-starter with attention to detail
- Team-oriented, but able to work independently and proactively
- Ability to multi-task
- Strong problem solving and organizational skills
- Strong critical thinking skills, including familiarity with root-cause analysis
Pay Range
$51,000 - $63,600
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. 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. Curia is an E-Verify employer.
Salary : $51,000 - $63,600
