Job Description
Job Description
Job Summary
The Quality Control Lab Technician will support production through routine analytical and microbiological laboratory testing of finished products and raw materials.
They are responsible for properly documenting test results, issuing deviations and conducting investigations to ensure the highest quality standards are met or exceeded.
providing recommendations to adjust process conditions to ensure compliance with FDA, state, and company standards.
Duties and Responsibilities
- Aseptic sampling of incoming raw materials for analytical and microbiological testing.
- Gather and initiate chain-of-custody documentation for all finished goods samples from filling lines for analytical testing and microbiological testing.
- Perform various laboratory tests, including but not limited to, FTIR, sensory, HPLC, ICP, wet chemistry techniques, and various microbiological testing per United States Pharmacopeia (USP) test methods.
- Enter test sample results into ERP, or Quality management system, and release product from Quality Hold.
- Support and provide quality expertise on product testing, out-of-specification (OOS) results, deviations, and investigations.
- Develop, document, and implement corrective actions approved by the Quality Control Manager due to laboratory investigations, and monitor for effectiveness.
- Perform statistical analyses of quality control data. Analyze and create trending reports for senior management.
- Create or modify standard operating procedures (SOPs) in accordance with FDA, USP and internal quality requirements.
- Perform other work as assigned by the Quality Control Manager
Education and Experience :
- Bachelor’s degree in chemistry or related field.
- 1-2 years of experience in a regulated environment, FDA experience preferred.
- Working knowledge of Good Laboratory Practices (cGLPs) and Good Manufacturing Practices (cGMPs).
- Experience performing analytical and microbiological tests :
- Routine microbiological tests plate counts (TPC) and basic identification techniques.
- Wet chemistry techniques.
- Sample preparation and analysis using FTIR, pH meter, Viscometer, HPLC, and ICP a plus.
Skills and Proficiencies
- Ability to work with minimal supervision, think analytically and with a high attention to detail.
- Ability to thrive in a fast-paced environment and pivot priorities based on business needs.
- Excellent verbal, written and cross-function team communication.
- Excellent troubleshooting and decision-making skills.
- Above average Mathematical Skills.
COMPANY BENEFITS
- Medical, Dental & Vision Insurance
- Flexible Spending Account
- Dependent Care Account
- Paid Time Off (PTO)
- Company Paid Short-Term Disability, Long Term Disability, & Life / AD&D
- 401k contributions
- Flex Time
- Volunteer Time Off
- Bereavement Time Off
- New Parent Paid Leave
- And more!
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