Chemist II Job Rochester area,City of Rochester New York USA,Quality Assurance

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe.

We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

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 in sourcing 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:

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.

Preferred Experience /

Competencies:

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.

Check out our US benefits here
- Employee Benefits:

Bausch + Lomb

This position may be available in the following location(s): [[]]

All qualified applicants will receive consideration for employment without regard to race, color,…