Quality Assurance Technician

Description

Perform in-process quality checks—including weight, thickness, hardness, disintegration, and friability—according to instructions in the manufacturing batch record. Conduct pre-manufacturing inspections of rooms and equipment by following detailed written procedures. Carry out Acceptable Quality Limit (AQL) sampling and inspections as required. Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab, ensuring accurate documentation and timely delivery of results. Maintain standard weight records and perform daily balance verifications. Properly isolate and document any rejected materials generated during batch processing. Monitor environmental conditions affecting both facility and product quality. Review engineering documentation, including temperature/humidity logs, calibration and preventive maintenance (PM) records, pest control logs, and contractor activity reports. Evaluate online batch records for completeness, including signatures, entries, and reconciliation/yield accuracy before proceeding to the next processing step. Confirm the functionality of all equipment and control systems during batch runs. Conduct relevant testing and prepare reports in response to customer complaints. Identify and escalate any non-conformances or discrepancies to management as needed. Perform additional duties or participate in special projects as assigned by management..

Skills

Quality assurance, Gmp, capa, sap, document control, pharmaceutical manufacturing, change control, deviation, batch record, mdi, document management, hplc

Top Skills Details

Quality assurance,Gmp,capa,sap,document control,pharmaceutical manufacturing

Additional Skills & Qualifications

Completion of advanced vocational training or a degree in pharmaceutical manufacturing, industrial management, or a related discipline from an accredited college or university is preferred. A minimum of 2-3 years of experience in quality assurance within a GMP-compliant pharmaceutical manufacturing environment. Prior experience with metered-dose inhalers (MDIs) or parenteral products is highly desirable.. 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 be a self-starter and demonstrate initiative with seeking additional training or direction as needed. Must have strong organization and leadership skills (written, verbal, and presentation). Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.

Experience Level

Intermediate Level