QA Analyst I

About the position

The purpose of the QA Analyst 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). The Quality Assurance (QA) Analyst position is an individual contributor role and a member of the InvaGen Pharmaceuticals Quality Team. The position reports to the Quality Assurance Manager and may be matrixed to other functional leaders within the Quality or other departments.

Responsibilities

• 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 following 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 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.

Requirements

• Minimum high school diploma.
• Minimum of three (3) years’ experience in a quality assurance in a GMP pharmaceutical manufacturing operation and work environment.
• Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications.
• 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.

Nice-to-haves

• Advanced vocational training or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university.
• Experience in MDI or parentals preferred.