Quality Control Technician in a Manufacturing Environment

The Quality Control Technician supports product quality and regulatory compliance through environmental monitoring, inspection, sampling, contemporaneous batch record review, and in-process quality verification activities in a sterile pharmaceutical manufacturing facility. The role serves as the first line of quality verification within manufacturing operations and is responsible for identifying and escalating quality concerns in a timely manner.

When will you work? 

• The hours for this position are Monday - Friday 8:00am-4:30pm.

What you'll do- Essential Responsibilities:

• Perform environmental monitoring activities including viable air sampling, surface sampling, personnel monitoring, and associated documentation according to approved procedures. Monitor storage conditions of the manufacturing environment, materials, and products.

• Prepare, package, and ship environmental monitoring and product samples to external contract laboratories. Review and retain all records associated with batch issuance, work instructions, release of product and all quality management data.

• Perform incoming material, component, packaging, and labeling inspections.

• Conduct in-process and finished product inspections.

• Perform contemporaneous review of batch production records during formulation, filtration, filling, inspection, packaging, labeling, and related manufacturing operations.

• Verify calculations, material identification, equipment status, line clearance activities, and production documentation.

• Review manufacturing records for completeness, legibility, and compliance with Good Documentation Practices (GDP) and Data Integrity.

• Monitor manufacturing and storage environmental conditions and report abnormalities.

• Maintain retain sample inventories and associated records.

• Assist with environmental monitoring excursions, investigations, and quality event documentation.

• Generate routine quality data and support trend analysis activities.

• Participate in inspections, audits, and continuous improvement initiatives.

Who you are (Knowledge, Skills and Abilities):

• Strong communication skills

• Ability to adapt to changing priorities and circumstances 

• Ability to identify and escalate quality concerns

• Ability to work in a dynamic, fast-paced and timeline-driven environment with shifting priorities

• Strong attention to detail

• Strong understanding of Microsoft Office and Excel software

• Good Documentation Practices (GDP)

• Ability to follow written procedures

• Basic mathematical and calculation skills

What you've done:

• Minimum one year experience in manufacturing, laboratory, quality, food, pharmaceutical, veterinary, medical device, healthcare, or other regulated environment preferred. 

• High School Diploma or GED required. 

Preferred Qualifications:

• Environmental monitoring experience.

• Quality inspection experience.

• Batch record review experience.

• Pharmaceutical, medical device, veterinary, or food manufacturing experience.

What’s in it for you: 

• A comprehensive benefits package that includes health, dental, and flexible spending accounts 

• 401(k) retirement plan with a generous company contribution to help you save for the future 

• Company Paid Life and disability insurance 

• Access to voluntary insurance options 

• A generous paid time off program that increases every year 

• Tuition reimbursement 

• Opportunity for growth - We believe in promoting from within and do so through our internal job posting program! 

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