Senior Quality Assurance Specialist - Rensselaer, NY

Job Description

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Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Job Description

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.

Additional Qualifications / Responsibilities

Qualifications :

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

Pay Range : $103,000 - $129,300