What are the responsibilities and job description for the Quality Control Chemist I position at Source One Technical Solutions?
Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a global medical device manufacturer, in Johns Creek, GA.
Title: Quality Control Chemist I
Location: Johns Creek, GA
Onsite, Monday to Friday
Contract Duration: 24 months, with likely extension
w2 Hourly Rate: TBD
Work Schedule: 12-Hour Shifts
Job Description
We are seeking a skilled Quality Control Analyst to perform comprehensive quality testing on materials and production samples, ensuring compliance with cGMP, FDA regulations, and Corporate Quality policies. This role supports production operations through routine and non-routine incoming inspections, assists in technical problem-solving, and communicates material dispositions to internal and external stakeholders with minimal supervision.
Key Responsibilities
- Conduct quality control testing on raw materials, in-process formulations, and finished product samples to support production operations.
- Maintain the Analytical Laboratory in compliance with regulatory standards and site procedures.
- Accurately document and review analytical data and laboratory records in a timely manner.
- Conduct lab investigations and participate in special analytical and incoming inspection projects as assigned.
- Complete ongoing training to stay current with industry best practices and maintain analytical proficiency.
- Engage in continuous improvement initiatives by identifying non-value-added activities and proposing enhancements.
- Execute routine procedures with supervisory guidance, including:
- Obtaining and inspecting packaging material samples.
- Preparing raw material samples for testing and submitting them to designated test areas.
- Managing material disposition in SAP and ensuring proper labeling.
- Prepare reports, emails, and memos for internal and external stakeholders following supervisory approval, including:
- Quality Reports (QR), material disposition notifications, non-conformance reports, and operational memos.
- Assist with non-routine procedures under supervisory direction, including validation studies, protocol execution, R&R studies, and vendor/site support projects.
- Support laboratory system administration, including:
- Lab safety oversight, calibration management, documentation maintenance, data trending, and inventory tracking.
- Maintain compliance with required training on SOPs, GMP, and safety protocols.
- Provide and receive cross-training within the Analytical and Incoming Inspection Laboratory to enhance operational efficiency.
Requirements
- Bachelor's degree in a scientific discipline (Chemistry preferred).
- Fluency in reading, writing, and verbal communication in English.
- 1–2 years of relevant experience in quality control or laboratory operations.
- Availability to work a 12-hour shift schedule.
