QA Inspector I

Description

• The QA Inspector (Manufacturing) is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing in compliance with established specifications.

Essential Functions

• Responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing or packaging in compliance with established specifications
• Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
• Perform room and equipment checks (where applicable) prior to each stage of manufacturing process as guided through written procedures.
• Perform AQL, Blend sampling, In-process Sampling, and inspections as required.
• Prepare in-process and finished product samples (where applicable) for QC lab, following detailed documentation procedures and delivering them to QC lab.
• Maintenance of standard weights and perform daily verification of balances which includes physically carrying ability of 100 kg (25 Kg x 4 No’s) weights for multiple 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 (temperature and humidity data calibration and PM records, Pest control records and contractor related functions).
• Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.
• Verification of 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/discrepancies to management if applicable.
• Other duties that management may assign from time to time.

Qualifications

• Associate degree diploma or equivalent (required); strong background in science preferred.

Experience

• 2–3 years of pharmaceutical industry experience, particularly in manufacturing or packaging (preferred).

Skills

• Proficient user of personal computer hardware and software applications such as Microsoft Office, SAP, and other business applications.
• Strong knowledge of GMP, regulatory requirements (FDA), and pharmaceutical manufacturing processes.
• Prior experience in RX and generic pharmaceutical manufacturing/packaging is a plus.
• 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)
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines