QA Inspector I - 3rd Shift
- 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.
- 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.
- Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications.
- Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
- Effective interpersonal relationship skills and the ability to work in a team environment.
- Proficiency in the English language to include usage, spelling, grammar and punctuation.
- Must have current Good Manufacturing Practices (cGMP) knowledge.
- Must have strong attention-to-detail.
- Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
- Must have strong organization and communication skills (written, verbal, and presentation).
- Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.
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