QUALITY ASSURANCE TECHNICIAN II

Job Description

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.

QUALIFICATIONS:

• High school diploma or general education degree (GED).
• 2+ years of experience in a Quality Assurance environment and/or chemistry laboratory is preferable.
• 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.

At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.