Quality Inspector II (Monday-Friday Third Shift)

Bausch + Lomb•US-FL-Tampa, FL

2d•Onsite

About The Position

The Quality Inspector II is responsible for ensuring the quality of products and batch records from manufacturing departments. This role involves evaluating quality issues in collaboration with Manufacturing and Quality Assurance teams. The position requires adherence to standard operating procedures and GMP guidelines, monitoring in-process inspections, identifying and segregating suspect materials, and performing various checks on batch documents and components. The role also includes AQL sampling, LOTO procedures, line clearance, and delivering in-process samples. Collaboration with other departments such as Materials Management, Contract Manufacturing, Engineering, and Validation is expected, including assisting with protocols and studies. The inspector must identify and report non-conformances, assist the manufacturing team with batch document issuance, correction, review, and closure, including accountability and yield calculations. A key part of the role is completing documentation reviews and resolving outstanding issues before releasing products to Quality Assurance, as well as assisting with investigations and providing necessary information. The position also supports standardization, quality metrics, and manufacturing schedules. The Quality Inspector II must maintain awareness and compliance with GxP, ISO, and environmental health and safety procedures, and is responsible for personal development through procedural reading and training other QCs. Any other duties as assigned will also be part of the role.

Requirements

High School Diploma Required.
3+ years of pharmaceutical/FDA regulated facility or related field required.
Ability to work well with people and 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.
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.

Nice To Haves

Associates degree preferred.
Quality Control/Assurance experience preferred (not required).

Responsibilities

Follow standard operation procedures and review 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 identify suspect material and perform 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 conduct on line reviews.
Perform AQL sampling and document inspection results in the batch record.
Perform LOTO, product inspections, and line clearance duties per procedures. Perform shift change line verification.
Pull in-process sampling and deliver accordingly.
Interact with other departments including Materials Management, Contract Manufacturing, Engineering and Validation. Assist and execute 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.
Complete all required documentation review and work with the Manufacturing team to resolve outstanding issues before releasing to Quality Assurance.
Evaluate quality issues and assist with the investigations providing necessary information and documentation when needed.
Support and actively participate 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.