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Associate, QC Compliance
3 months ago
Job Description - Quality Control Associate
We are looking for a dedicated Quality Control Associate to join our team. In this role, you will be responsible for performing a variety of quality control tests on raw materials, in-process, and final products. Your main focus will be ensuring compliance with approved test methods and Standard Operating Procedures (SOPs) while adhering to current Good Manufacturing Practices (cGMPs). You will also play a key role in monitoring systems, evaluating data, and maintaining documentation.
Responsibilities:
- Conduct a range of quality control tests on raw materials and products
- Utilize various test methods following GLPs, USP, and EP standards
- Maintain, calibrate, and evaluate laboratory equipment
- Analyze and interpret data, keeping accurate records
- Support internal and external audits to ensure compliance with industry standards
- Assist in the timely closure of quality management system records
- Prepare samples for testing and collaborate with external laboratories
- Perform routine maintenance on laboratory instruments
- Follow established procedures for workflow and waste disposal
- Train for Visual Inspection qualifications
- Other duties as required
Work Conditions:
- Office and laboratory settings
- Exposure to noise, heat, and chemicals requiring safety equipment
- Handle hazardous chemicals and materials
- Work under specific safety protocols with various substances
Physical Requirements:
- Ability to perform various physical tasks
- Close vision and attention to detail
- Lift up to 25 lbs.
- Operate office equipment and wear protective gear
Education and Qualifications:
- B.S. in a relevant scientific field
- Strong communication and analytical skills
- Familiarity with wet chemical methods and instruments
- Knowledge of cGMPs and GLPs
- Proficiency in computer applications
Experience:
- Minimum 2-4 years of related experience
- Experience with Trackwise, Novatech, and Empower software
Disclaimer: This job description outlines the primary responsibilities of the role and the qualifications required. It is not exhaustive and may be subject to change to suit the needs of the business. The employer reserves the right to modify duties and requirements as needed based on the incumbent's background and skillset.