Reference Standard Coordinator

Company Description

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Job Description

Principally responsible for leading the reference materials program including performing qualification testing not limited to: HPLC, KF, FTIR, GC, UV-Vis, and TGA to ensure site support and customer requirements are met. Maintains QC controlled substance sample tracking inventory and leads destruction and inventory efforts. Evaluates compendia updates for site impact and coordinates implementation.

• Apply scientific knowledge to perform qualification of reference materials following all Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs).
• Schedule and conduct analyses and interpret results accurately and defensibly for reference standards. Review data, write associated reports, and issue CofT or CofA as required.
• Maintain inventory of reference standards and markers. Follow plant manufacture and stability testing schedule to ensure availability of needed reference material.
• Keep current with regulatory and requirements and trends as related to reference standards.
• Shipment of reference materials for client requests and external laboratory testing.
• Work together with EH&S for the creation of SDS for new reference material.
• Maintain a working knowledge of DEA and import/export procedures and requirements for controlled substances.
• Maintain controlled substance records in both paper and LIMS systems as appropriate.
• Direct controlled substance inventory/discard process. Provide timely documentation to site DEA Specialist.
• Review quarterly compendia update newsletter and initiate MOCs for site impact.
• Contribute to regulatory submissions and responses.
• Collaborate with Analytical Development, Chemical Development, Business Development, Commercial, Regulatory, and Project Management departments along with other JM sites and customers.
• Revise/create SOPs.
• Contribute to laboratory organization and compliance/audit readiness. Participate in quality audits with FDA, other regulatory agencies and customers.
• Other duties as assigned.

Qualifications

• BS in Chemistry or equivalent with at least 5 years related experience in a pharmaceutical Quality Control environment.
• Experience with common analytical techniques such as: HPLC, GC, UV, pH meter, KF, FTIR.
• Ability to read, analyze, and interpret English-language chemical periodicals, scientific journals, and regulatory documents.
• Ability to write clear and concise technical reports.
• Ability to work independently with minimal supervision and in a team environment.
• Good written and verbal communication skills. Experience communicating effectively to management.
• Good understanding of Microsoft Office.
• Demonstrate ability to exercise good judgment and make decisions quickly.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.