What are the responsibilities and job description for the Quality Assurance Specialist I position at curiate.co?
Job Description
Quality Assurance (QA) Specialist I in Springfield, MO
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
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.
Summary :
The Quality Assurance (QA) Specialist I is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to operations. This role includes identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action. The QA Specialist I primarily works in the cGMP areas to manage adherence to the quality system and initiate the resolution of deviations.
Supervisory responsibilities :
This position does not have supervisory responsibilities.
Responsibilities :
- Assist in developing and conducting training of personnel in full accordance with cGMPs and Curia's quality system to ensure real-time compliance
- Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented
- Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations
- Assist in Curia documentation compilation, systems and controls to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for domestic and international inspections and registrations
- Author, revise and / or review and approve Quality Management System documents, including, but not limited to, SOPs, CAPAs, Deviations, Un-executed / Executed quality records, Change Controls, test methods, protocols (stability, validation, etc.), executed validation documentation, certificates of analysis and / or equipment qualification documentation
- Assist in internal and external audit programs and prepare reports as required. This may include planning audits, conducting audits and writing audit reports
- Participate in and / or perform regulatory, client, and external supplier qualification audits as well as internal audits and weekly walkthroughs
- Assist in or lead investigations
- With supervision, may respond or manage responses to clients regarding manufacturing, testing, and / or documentation issues
- Assist in tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs
- Develop, support and / or maintain Quality System metrics for management review
- Support QA specialists to ensure client timelines are on schedule and attainable. This includes communicating directly with internal project teams and customer contacts
- Assist in resolving quality problems / concerns with various personnel
- Provide on the floor support and oversight to operations, including coordinating and perform day to day activities as needed
- Actively participate in quality improvement initiatives, including development and implementation
Required Qualifications :
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
Preferred Qualifications :
Knowledge, Skills and Abilities :
Physical Requirements :
Work Environment :
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by
Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
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.
