QUALITY ASSURANCE TECHNICIAN II

LGM Pharma, LLC•Rosenberg, TX

About The Position

This role involves performing various inspections and testing during the production process to ensure product quality and adherence to specifications. The technician will work closely with the Production Team and QA Manager to resolve issues, review data, and maintain equipment. The position also supports audits and ensures compliance with GMP regulations and standard operating procedures.

Requirements

High school diploma or general education degree (GED).
Solid organization, attention to detail, and communication skills, both written and verbal.
Ability to routinely lift and move up to 50 pounds.
Able to stand for long periods of time.
Able to apply basic math concepts
Able to work with others in a positive team environment.

Nice To Haves

2+ years of experience in a Quality Assurance environment and/or chemistry laboratory is preferable.

Responsibilities

Perform initial, in-process, and final inspections during production.
Resolve any inspection issues with the Production Team and /or QA Manager.
Perform review of QA testing data.
Inspect incoming components for damage and adherence to approved specifications.
Coordinate collection of finished goods samples for all new and revised products to ensure that stability studies have been carried out in accordance with GMP or standards equivalent to GMP guidance.
Issue raw material and packaging components specification sheets.
Perform equipment and room clearances based on cleanliness and adherence to SOPs.
Perform and/or assist with batch record review for accuracy and completeness.
Coordinate the collection of in-process and finished-goods samples as needed.
Conduct analytical equipment and instrumentation calibrations as directed.
Maintain analytical equipment and instrumentation utilized for QA physical testing in accordance with written procedures.
Assist in preparation for internal, customer, and regulatory agency audits.
Assist QA Manager in ensuring all personnel comply with GMP regulations and follow all standard operating procedures.
Other duties as assigned.