Quality Assurance Associate

The purpose of the QA Manufacturing Inspector position is to monitor and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs).

Job Description:

• The position reports to the Manager of QA and may be matrixed to other functional leaders within the Quality or other departments. The essential and typically expected job duties for this position include but are not limited to the following:
• Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
• Conduct room and equipment checks (where applicable) prior to each stage of manufacturing by following detailed written procedures.
• Execute acceptable quality limit (AQL) sampling and inspections as required.
• Inspect in-process and finished product samples (where applicable) for the Quality Control (QC)
• Lab and follow detailed documentation procedures to deliver the results to the QC Lab.
• Maintain records of standard weights and perform daily verification of balances.
• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.
• Monitor facility and product environmental operating conditions.
• Review of engineering records such as temperature and humidity data calibration and PM records, Pest control records and contractor related functions.
• Assess online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.
• Verify the functionality of all the equipment and associated controls during the batch run.
• Perform applicable testing and prepare reports for customer complaints.
• Identify and report any non-conformances and/or discrepancies to management if applicable.
• Complete other duties or participate in project work as assigned by management.

EDUCATION AND EXPERIENCE QUALIFICATIONS

• Minimum high school diploma.
• Advanced vocational training or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university is preferred.
• Minimum of three (3) years’ experience in quality assurance in a GMP pharmaceutical manufacturing operation and work environment.
• Experience in MDI preferred.

Job Type: Full-time

Pay: $80,219.00 - $90,326.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Night shift

Experience:

• Pharmaceutical: 4 years (Preferred)

Work Location: In person

Salary : $80,219 - $90,326