Chemist II

Responsibilities

• Serve as the primary analyst supporting the internal Reference Standards program.
• Evaluate materials proposed for use as reference standards and determine appropriate characterization methodology to meet business needs.
• Cook up and coordinate testing of reference standard samples with laboratory analysts to ensure timely completion and reporting of results.
• Author characterization protocols, characterization reports, and reference standard protocols.
• Review reference standard protocols to ensure testing is accurate, compliant with current applicable pharmacopeial requirements, and that the reference standard purity assignments are scientifically justified.
• Continuously improve existing methods and reference standards by staying current with pharmacopeial updates, business needs, and technical capabilities.
• Identify opportunities to reduce external testing costs and improve program efficiency by insourcing testing activities when feasible.
• Participate in Reference Standard Review Board meetings and collaborate cross-functionally to support new and existing reference standards.

Qualifications

• Education: Bachelor's degree (BS) in Chemistry or related scientific field preferred, with a minimum of 2 years of experience preferably in an FDA regulated industry.
• Associate of Applied Science (AAS) degree in Chemistry or related scientific field, with a minimum of 5 years of relevant experience, preferably in pharmaceutical or medical device industry.
• Equivalent combinations of education, specialized training, and experience may be considered.
• Candidates with 5+ years of relevant experience in the pharmaceutical or medical device industry may be considered in lieu of related degree.

Additional Responsibilities

• Support general laboratory housekeeping activities, including reference standard inventory management, sample disposal, sample closeout and archiving.
• Assist with Lab Control and Compliance Team activities, as appropriate.
• Communicate monthly status updates and pending actions to relevant stakeholders.
• Assist with reference standard distribution activities.
• Conduct nonconformance investigations and laboratory investigations related to out of tolerance (OOT) and out of specification (OOS) results.