Quality Inspector II (Monday-Friday Third Shift)

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.