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Form of workCuria provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The QA Specialist II is responsible for maintaining quality databases and providing routine on-the-floor QA presence and oversight to the manufacturing operation. The QA Specialist'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.
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.
We proudly offer
Generous benefit options (eligible first day of employment)
Paid training, vacation and holidays (vacation accrual begins on first day of employment)
Career advancement opportunities
Education reimbursement
401k program
Learning platform
And more!
Responsibilities
- Responsible for working cross-functionally with Manufacturing, Process Engineering, Facilities, Inspection, and Project Management on Quality Assurance (QA) activities such as executed/unexecuted batch record review, executed/unexecuted validation/facility protocols/reports, reviewing change controls, and reviewing facility work orders prior to filing
- Educate and train manufacturing/process engineering personnel to execute production in full accordance with cGMP's and AMRI's quality system to ensure real-time compliance
- Represent Curia's Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and appropriately documented
- Reviews un-executed /executed batch records and quality control testing for compliance with internal SOPs and specifications
- Monitor Operations personnel for adherence to SOP's. Report back to Manager of QA as well as area functional management as to personnel performance, highlighting those areas and individuals in need of improvement
Pay Range:
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.
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