Senior Quality Assurance Specialist

Curia•City of Rensselaer, NY

About The Position

Senior Quality Assurance Specialist in Rensselaer, NY 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. We proudly offer Generous benefit options Paid training, vacation and holidays Career advancement opportunities Education reimbursement 401k program And more! In this role, you will: Assist the Quality Assurance Manager in ensuring compliance with all Quality Management Systems and Regulatory Agency requirements (e.g., FDA, EMA, MHRA, etc..) for the Rensselaer site. Conduct investigations of OOS, Deviations, Change Control Management, and CAPAs Work cross-functionally with other departments on Analytical Quality Assurance activities such as reviewing various documents, protocols, qualifications and/or reports related to Quality Management Systems. Develop and/or review and/or approve quality standards, policies, and procedures for all functions and departments involved in cGMP activities. Support all the Regulatory Agency inspections at the site and the preparation of CAPAs and monitor the completion of assigned tasks. Lead and drive the GMP activities, work with manufacturing Managers and supervisors to complete the deviation investigations on time Responsible driving the established Quality Metrics Review and approve master batch records as and when required. Manage all the customer audits at the site, lead the preparation of CAPAs, and monitor their completion providing updates to customers and management. Report serious or repeated observations or serious compliance gaps to quality management. Manage the Internal Audit program including coordination of auditors within the QA department. Interact with the Curia Quality network to share information related to quality expectation, inspections, audits, facilitating harmonization of quality system within Curia.

Requirements

Minimum Bachelor of Science degree in Chemistry or a related field
Minimum 8 years QA, RA or Compliance experience in pharmaceutical industry (preferred in APIs) at USFDA regulated facilities
Broad knowledge of cGMP, FDA and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH).
Knowledge of pharmaceutical processes.
USFDA inspection experiences (participating or leading)
Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross functionally across internal stakeholders.
Proficient in building consensus, negotiating and escalating issues
Good understanding of the importance and use of quality metrics

Responsibilities

Assist the Quality Assurance Manager in ensuring compliance with all Quality Management Systems and Regulatory Agency requirements (e.g., FDA, EMA, MHRA, etc..) for the Rensselaer site.
Conduct investigations of OOS, Deviations, Change Control Management, and CAPAs
Work cross-functionally with other departments on Analytical Quality Assurance activities such as reviewing various documents, protocols, qualifications and/or reports related to Quality Management Systems.
Develop and/or review and/or approve quality standards, policies, and procedures for all functions and departments involved in cGMP activities.
Support all the Regulatory Agency inspections at the site and the preparation of CAPAs and monitor the completion of assigned tasks.
Lead and drive the GMP activities, work with manufacturing Managers and supervisors to complete the deviation investigations on time
Responsible driving the established Quality Metrics
Review and approve master batch records as and when required.
Manage all the customer audits at the site, lead the preparation of CAPAs, and monitor their completion providing updates to customers and management.
Report serious or repeated observations or serious compliance gaps to quality management.
Manage the Internal Audit program including coordination of auditors within the QA department.
Interact with the Curia Quality network to share information related to quality expectation, inspections, audits, facilitating harmonization of quality system within Curia.