Supervisor, Quality Control Stability

Curia • City of Rensselaer, NY

1d • $87,000 - $108,576 • Onsite

About The Position

The Quality Control Stability Supervisor is primarily responsible for overseeing routine analytical chemistry assays of stability samples, with occasional testing of raw materials, in-process samples, finished APIs, and/or special projects. This role will oversee the day-to-day functions of their department and manage a team of Quality Control Chemists focused on stability testing. This position may require work outside of normal business hours as needed.

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.

Requirements

• Bachelor’s degree in Chemistry, Analytical Chemistry, or related field
• Minimum 5 years’ experience in a GMP or FLP environment working with Chromatography (HPLC/UPLC/GC), extensive method development and/or validation, including a minimum of 2 years supervisory experience
• Strong oral and written communication skills, including effective listening
• Demonstrated ability to effectively utilize team resources
• Expert in cGMP, USP, EP and FDA regulations
• Ability to recognize what needs to be done, take action, and accomplish results
• Technical competence including the understanding of theory and interpretation of all lab techniques
• Proficient use of computer software, including Microsoft Office Suite (excel, word) and other required software
• Strong organizational skills with the ability to multi-task
• Proficient in HPLC and GC method development and method validation with extensive experience with multiple other analytical techniques and analytical equipment
• Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485, and ICH Stability guidelines.

Responsibilities

• Manage the Quality Control Stability Team Performance of analytical testing for various stability samples and incoming, in process and final products
• Ensure that the analytical chemistry functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely
• Supervise a team of scientists including, but not limited to, the motivation, education, efficiency, performance management and productivity of these individuals
• Ensure that laboratory operations are conducted in a safe manner. Remain familiar with the contents of the Chemical Hygiene Plan. Follow safety rules fully
• Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMPs as necessary
• Organize workloads and coordinate activities in order to carry out multiple projects concurrently and in accordance with established objectives, timelines and deadlines
• Conduct investigations of OOS, Deviations, Change Control Management, and CAPAs
• Supervise and perform pharmaceutical analysis to support drug product manufacturing

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
• Learning platform

What This Job Offers

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