Compliance Specialist II; Analytical Development

Curia is a global contract development and manufacturing organization serving pharmaceutical and biotech companies. The Compliance Specialist II supports analytical development and product development by ensuring compliance with cGMPs, company and customer quality standards, and regulatory requirements while managing quality events, audits, SOPs, investigations, and laboratory compliance activities.

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
• Assist 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

Preferred

• Experience in Analytical instrument qualification and conducting investigations for Quality events is desirable
• Analytical Instrument Qualification
• Quality Event Investigations

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

Company

• Biologics and small molecule CDMO
• Albany, New York, USA
• https://curiaglobal.com/
• Founded in 1991
• 1001-5000 employees

Qualifications

• MS or BS Degree in technical discipline such as science or engineering or experience in a laboratory or chemical manufacturing environment. Will substitute relevant experience in lieu of educational requirements
• MS degree and minimum of one (1) year or BS degree and minimum of three (3) years of industrial cGMP experience in an FDA-regulated pharmaceutical environment. Will substitute relevant experience in lieu of educational requirements
• Proficiency in technical writing (e.g quality events, change controls, SOPs, protocols, reports, etc)
• Knowledge of FDA and ICH guidance for pharmaceuticals is required
• Experience in Analytical instrument qualification and conducting investigations for Quality events is desirable
• MS degree and minimum of one (1) year or BS degree and minimum of three (3) years of industrial cGMP experience in an FDA-regulated pharmaceutical environment. Will substitute relevant experience in lieu of educational requirements.

Required skills

• Analytical Instrument Qualification, Change Control, Corrective and Preventive Action (CAPA), Current Good Manufacturing Practices (cGMP), FDA Regulations, ICH Pharmaceutical Guidance, Quality Event Investigations

Experience

• 1-3 years