What are the responsibilities and job description for the Quality Assurance Specialist position at Curia?
Curia Global Inc. (Burlington, MA) seeks a Quality Assurance Specialist. Responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to operations. Identify compliance risks in the operation prior to and during execution, avoiding deviation whenever possible and managing immediate corrective action. Work in the cGMP areas to manage adherence to the quality system and initiate the resolution of deviations.
Specifically, this position will perform the following duties:
- 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, 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; and
- Actively participate in quality improvement initiatives, including development and implementation.
There are two job openings available for this position.
REQUIREMENTS: The position requires a bachelor’s degree (or foreign equivalent) in Chemistry, Regulatory Affairs or a related field. The successful candidate must also have two (2) years of experience as a quality assurance specialist in the pharmaceutical field. Alternatively, the position requires a master’s degree (or foreign equivalent) in Chemistry, Regulatory Affairs, or a related field.
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.
