Stability Coordinator I

Major Duties and Responsibilities

• Review of analytical data and documentation for compliance with cGMPs, Curia SOPs and other written procedures, primarily chromatographic data but also instrumental testing such as DSC, XRPD, water analysis, USP testing; identification of deviations; trending of stability data to ensure consistency with historical timepoints and no unexpected results.
• Managing timelines and multiple projects: interface with scientists and management to coordinate testing timelines, corrections to documentation, and reporting within defined turnaround times; adjusting priorities based on due dates and invoicing goals.
• Writing stability protocols.
• Interfacing between sites (Albany and Rensselaer) to coordinate testing for efficiency and use of site-exclusive equipment.
• Direct, technical communication with customers (primarily external): reporting results, technical discussion, addressing questions.
• Formatting and review of reports: Stability Summary tables; accuracy and compliance with current Curia formats.
• Managing invoicing for stability: request of POs for contract laboratories, issuing BRFs, working with finance to ensure accurate and complete accounting for stability projects, review of monthly invoices; tracking monthly and quarterly financial projections.
• Controlled substances handling including maintaining inventory, paperwork, biannual review.
• Manage quality investigations (e.g., deviations) as necessary.
• Manage workload and time to enable the incumbent to perform multiple projects effectively, and ensure all necessary paperwork is completed on a timely basis.
• Volunteer to assist with other tasks in the analytical function not directly related to specific projects.
• Participate in self-development activities and training of others.
• Perform other related duties as may be reasonably assigned in the course of business.
• Future: writing proposals and designing studies for stability.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience

• Bachelor's degree in a relevant field with major in Biology, Chemistry, Natural Science or Pharmacy or equivalent required with minimum of 2+ years of previous professional experience
• Good knowledge of analytical chemistry including wet chemistry and instrumental methods of analysis
• Strong computer and math skills
• Demonstrated written & verbal skills
• Technical troubleshooting skills
• Critical thinking & problem-solving skills such as DMAIC
• Analytical data review
• Experience with ERP, LIMS and document control systems preferred

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening