Quality Inspector II

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.

Objectives/Purpose of the Job:

The assurance of quality product and batch records from the manufacturing departments. Evaluates quality issues with Manufacturing and Quality Assurance.

Key Activities/Responsibilities/Job Functions:

• Follows standard operation procedures and review to batch records to ensure compliance with Good Manufacturing Practices (GMP), accuracy, completeness, and accountability.
• Monitor and conduct in process inspections in the manufacturing area, implementing proper documentation practices, applicable visual inspections, testing intervals and/or methods, as per batch record instructions and current SOP.
• Properly identifies suspect material and performs segregation procedures, or when instructed by QA management and/or per provided written instructions.
• Check batch documents to ensure product, lot number, expiration dates and all components are correct, and conducts on line reviews.
• Performs AQL sampling and documents inspection results in the batch record.
• Performs LOTO, product inspections, and line clearance duties per procedures. Performs shift change line verification.
• Pull in-process sampling and deliver accordingly.
• Interacts with other departments including Materials Management, Contract Manufacturing, Engineering and Validation. Assists and executes protocols and studies.
• Identify and inform applicable departments in the event of a potential or observed nonconformance.
• Assist the manufacturing team with the issuance, correction and review of batch documents.
• Assist Manufacturing team as needed with batch record reviews and batch record closure on each line at the end of the run including accountability and yield calculations.
• Completes all required documentation review and work with the Manufacturing team to resolve outstanding issues before releasing to Quality Assurance.
• Evaluates quality issues and assists with the investigations providing necessary information and documentation when needed.
• Supports and actively participates in standardization and Quality metrics.
• Support of manufacturing schedules and changes.
• Assume the responsibility for the GxP, ISO, and environmental health and safety procedure awareness and compliance within the respective area.
• Maintain compliance to GxP and procedural reading, personal development.
• Perform training of other QCs.
• Any other duties as assigned.   

Qualifications /Training:

• Associates degree preferred. High School Diploma Required.
• Quality Control/Assurance experience preferred (not required).
• Ability to work well with people an independently.
• Be able to follow written and verbal instructions and ability to read and understand SOP's.
• Excellent time management skills and attention to detail is critical.
• Maintain QC, line clearance and visual inspection certifications. Able to work independently with little supervision.
• Ability to escalate/solve shop floor issues per procedures and utilizing analytical and critical thinking skills.
• 3+ years of pharmaceutical/FDA regulated facility or related field required.

Eligibility for Internal Applicants:                                                                                                          

• Have no corrective actions at the written warning level in last six months/no final warning level in the last 12 months/no active PIP. 
• Meet the qualifications of the position as stated above.                                                     
• Be in your current job for 12 months.
• Position applying for must be a step up in progression and not a step down.                                                                                                

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.

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.