Chemist II

Bausch + Lomb•US-NY-Rochester, NY

7d•Onsite

About The Position

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.

Requirements

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.
Applicants must be authorized to work for ANY employer in the U.S.
We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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.
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.
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.