Reference Standard Coordinator

Reference Standard Coordinator – Albany, NY

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The principal responsibility of the Reference Standards Coordinator is the coordination of the analyses of active pharmaceutical ingredients, chemical intermediates, and target compounds. The Reference Standards Coordinator is expected to demonstrate expertise in both the theoretical and practical aspects of analytical chemistry. A major component in the Reference Standard Coordinator’s performance rating will be based on productivity. In general, technical, organizational and compliance support for Curia’s reference standards program.

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.

We proudly offer

• 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
• And more!

Responsibilities

• Review of analytical data and documentation for compliance with cGMPs, CURIA SOPs and other written procedures. This includes chromatographic data as well as non-chromatographic data such as DSC, XRPD, water analysis, USP testing, etc.
• Technical review of standard recertification data to ensure consistency with historical results and identification of quality events
• Managing paperwork and files associated with active and inactive reference standards
• Assigning reference standard purities; issuing labels and certificates of analysis. Maintaining internal reference standard systems: organization, database, labeling
• Designing recertification plans for reference standards
• Managing timelines and multiple projects: Interface with scientists and management to coordinate testing timelines, corrections to documentation, and issuance of certificates of analysis within defined turnaround times
• Interfacing between CURIA sites to coordinate testing, and supply of reference standards to support production
• Communicate in a timely manner with PM’s and sister sites regarding reference standards that are running low so that any potential impact to manufacturing can be mitigated in advance
• Direct communication with customers (external and internal) and addressing questions re: reference standards
• Working with shipping to coordinate time sensitive deliveries of reference standards (including controlled substances) when requested by customers (including generation of letters, shipping authorizations, etc.)
• Process and submit billing Release Form (BRF) to Finance Department for each reference standard shipped to CURIA customers
• Recommend technical revisions to reference standard SOPs, regulatory documents, and internal procedures in order to create new areas of productivity efficiencies
• Directly coordinate replacement of depleted/inactive reference standard materials with CURIA production site and/or SSM
• Submit complete, documented, and legible reports of analytical testing. Ensure that data is properly filed and accessible for review in accordance with appropriate SOP’s
• Recommend and implement methods to increase the quality of products and/or services
• Establish new and improved ways to perform job by challenging established procedures
• Discuss routinely with supervisor the status of assigned programs and potential problems
• 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. Provide orientation and train new personnel on operating procedures and policies
• Perform other related duties as may be reasonably assigned in the course of business
• Provide weekly progress report to manager in a weekly meeting

Qualifications

• Bachelor’s Degree in Chemistry or related field
• 5 years of experience

Pay Range : $31.25 - $38.82/hr.

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia 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. Curia is an E-Verify employer.