Senior Quality Assurance Specialist, Rensselaer NY XXXX provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Senior Quality Assurance Specialist is an integral part of the XXXX team, contributing to our success by ensuring proper implementation of the quality systems at the site keeping them current and in line with applicable regulation and Corporate standards. As the Senior Quality Assurance Specialist you will oversee the site quality compliance and make recommendations for corrective action necessary to ensure conformity, driving continuous improvement initiatives.
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. In this role, you will:
• Assist the Quality Assurance Manager in ensuring compliance with all Regulatory Agency requirements (e.g., FDA, EMA, MHRA, etc..) for the Rensselaer site
• 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 their completion providing regular updates to management.
• 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 Head of Quality Assurance.
• Maintain evidence files for all regulatory inspections and customer audits.
• Manage the Internal Audit program including coordination of auditors within the QA department.
• Interact with the XXXX Quality network to share information related to quality expectation, inspections, audits, facilitating harmonization of quality system within XXXX.
• Leads Regulatory Agencies inspections and Customer audits.
• Oversee SOP, training document and records management systems.

Qualifications

Qualifications and background to be successful in this role: Required
• Minimum Bachelor of Science degree in Chemistry or a related field
• Minimum 5 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 Preferred
• Auditing experience is preferred
• Prior supervisory experience is preferred All interested applicants must apply online. XXXX 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.