Compliance Specialist III; Analytical Development

Curia • Albany, NY

1d • Onsite

About The Position

Compliance Specialist III supports new products and existing product development by working to ensure compliance with cGMPs, company and customer quality standards as well as external regulatory requirements. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

Requirements

• Master’s degree and minimum of three (3) years’ or Bachelor’s degree and minimum of five (5) years of industrial cGMP experience in an FDA-regulated pharmaceutical environment.
• Proficiency in technical writing (e.g quality events, change controls, SOPs, protocols, reports, etc.).
• Knowledge of FDA and ICH guidance for pharmaceuticals is required

Nice To Haves

• Experience in Analytical instrument qualification and conducting investigations for Quality events is desirable

Responsibilities

• Develop and maintain a strong command of SOPs, cGMPs and associated regulations. Apply this knowledge in the everyday work environment, providing consultation as necessary
• Develop an understanding of the function and basic operation of analytical equipment and techniques to enable effective performance of other duties
• Monitor compliance in the Analytical laboratories and actively participate in resolving quality issues
• Identify quality system improvements and recommend methods to increase the quality of products and/or services. Participate in the implementation of these improvements
• Assist Analytical staff with change control and CAPA processes, writing deviations and investigations. Identify areas of concern and communicate to management
• Track and manage timelines for analytical quality events and initiatives. Coordinate efforts to ensure timelines are met and when necessary, assist staff with extension requests
• Coordinate periodic review and revision of SOPs
• Review and/or approve (where applicable) SOPs, material specification forms, test methods, instrument qualification protocols/reports, vendor repair/calibration reports, etc.
• Assist Analytical staff with review and approval of equipment qualification documentation, including protocols and reports
• Assist Analytical staff with training programs for new hires as well as ongoing compliance awareness for the department
• Represent Analytical during regulatory, client, and internal audits including tours of Analytical laboratory areas
• Coordinate Analytical responses generated from regulatory, client, and internal audits. Engage relevant subject matter experts to assist with responses when necessary
• Perform all duties safely in accordance with Curia Safety Program, OSHA requirements, FDA regulations, and all applicable federal, state and local regulations
• Communicate within Analytical as well as with development chemists, Small Scale Manufacturing chemists, Quality/Regulatory personnel, Receiving personnel, maintenance and engineering personnel, information systems personnel and specific members of management (when requested)
• Participate in self-development activities
• Exhibit safety awareness and safe work practices
• Perform other related duties as may be reasonably assigned in the course of business

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level