Valeant Pharmaceuticals

In Process Inspector III

Job Location US-FL-Tampa
Job ID
9754
Pos. Category
Quality
Pos. Type
Full Time

Overview

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

Responsibilities

  • Follows standard operation procedures and reviews 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 specific instructions and current SOP.
  • Properly identifies suspect material and performs segregation per 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 LO/TO, product inspections, and line clearance duties per procedures.  Perform shift change line verification.
  • Pull in-process sampling and deliver accordingly.
  • Interacts with other departments including  Materials Mgmt, 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 investigations providing necessary information and documentation when needed.
  • Supports and actively participates in standardization and Quality metrics.
  • Support of manufacturing schedule 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.
  • Back-up to QC Group Leader, when necessary
  • Any other duties as assigned.

 

Qualifications

This position is 3rd shift (11:00pm - 7:30am)

Associates degree preferred.  High School Diploma required.

 

This position requires quality control/assurance experience. 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 details is critical. Maintain QC, line clearance and if assigned, aseptic gowning certifications.  Able to work independently with little supervision.  Ability to solve shop floor issues per procedures and utilizing analytical and critical thinking skills. 

 

5+ years of pharmaceutical/FDA regulated facility or related field required. Manufacturing and/or quality control experience in an aseptic manufacturing environment highly desirable. 

 

Tools and Equipment Used:  Numerous hand tools for assembling and disassembling filling equipment, mirrors, forceps, ruler, calculator, computer, microscope, scales, torque meter, automated check weigher, stopwatch and AQL ruler.

 

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