Quality Assurance Specialist I

Date: Jan 20, 2025

Location: US-NY-Rochester, New York, US

Company: Bausch + Lomb

 

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 world—from 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:
The Quality/Stability Specialist performs activities required to maintain a stability program that meets ISO/FDA and ICH regulations for marketed and pre-marketed formulations according to established procedures. 

 

Responsiblities:
•  Coordinate and conduct stability studies in support of marketed and pre-marketed formulations. This includes both internal and external stability programs.
•  Author/review stability protocols, annual reports, stability summaries and SOPs. 
•  Monitor ongoing stability studies to ensure commitments are met. 
•  Provide access to stability data for other purposes upon request.
•  Use of laboratory information management system (LIMS) to support testing and documentation of stability studies.
•  Assist in leading day-to-day activities within Stability Operations to ensure that strategic objectives are successfully met in a timely manner.
•  Sample receipt, staging of product and sample distribution to internal and external testing labs. 
•  Coordinate maintenance and repairs of stability chambers by facilities and outside contractors. 
•  Assist with general housekeeping including sample inventories, sample disposal, sample closeouts and archiving.
•  Create Purchase Orders to ensure timely submission of invoices for payment.
•  Assist with budgeting and accrual activities.
•  Assist with Lab Control and Compliance Team activities.
•  Perform activities related to weekly stability pulls.
•  Assist with reference standard distribution.
•  Perform nonconformance and laboratory investigations for out of tolerance/out of specification data.

 

Qualifications:
•  BS in Chemistry, or related field with minimum 1 year experience preferably in an FDA regulated industry.
•  AAS in Chemistry, or related field, with minimum 5 years on-the-job experience, preferably in pharmaceutical or medical device industry, or equivalent through specialized training.
•  Excellent oral and written communication along with organizational skills.
•  Experience with LIMS.

 

We offer competitive salary & excellent benefits including:

  • Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
  • 401K Plan with company match and ongoing company contribution
  • Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time
  • Employee Stock Purchase Plan with company match
  • Employee Incentive Bonus
  • Tuition Reimbursement (select degrees)
  • Ongoing performance feedback and annual compensation review

 

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.

 

For U.S. locations that require disclosure of compensation, the starting pay for this role is between $61,000.00 and  $83,000.00.  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.

 

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch + Lomb's Job Offer Fraud Statement.

 

Our Benefit Programs: Employee Benefits: Bausch + Lomb

 

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.

 

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