Chemist II

Objective Perform activities required to ensure reference standards within the B+L program are evaluated, documented, maintained and controlled throughout their lifecycle in compliance with regulatory requirements and internal quality standards. Responsibilities Serve as the primary analyst supporting the internal Reference Standards program. This includes evaluating materials proposed for use as reference standards and determining appropriate characterization methodology to meet business needs. 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. Maintain technical knowledge and skills through participation in applicable training programs. Maintain a safe and compliant work environment by adhering to company policies, procedures, and regulatory requirements. Additional responsibilities may include 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. Qualifications 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. Strong analytical problem solving skills. Working knowledge of cGMP requirements and data integrity principles. Excellent written, verbal, and organizational skills. Experience with Laboratory Information Management Systems (LIMS). Ability to work effectively in cross-functional teams and manage multiple priorities. What We Offer Comprehensive health, wellness, and retirement benefits. Paid time off and programs that support work-life balance. Opportunities to learn, grow, and contribute to meaningful work. This position may be available in the following location(s): US - Rochester, NY (GEHC) Equal Employment Opportunity Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Compensation For U.S. locations that require disclosure of compensation, the starting annual pay for this role is between $71,000.00 and $80,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors. U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation. #J-18808-Ljbffr