Position Overview
The Quality Control Technician at our 503B outsourcing facility is responsible for ensuring that all products meet the highest standards of quality and safety before they reach our clients. This role involves performing various tests and inspections on raw materials, in-process samples, and finished products, and environmental monitoring in cleanroom environments. The Quality Control Technician will work closely with production, quality assurance, and other teams to identify and resolve any quality issues, maintain accurate documentation, and support continuous improvement initiatives. This position requires a strong understanding of Good Manufacturing Practices (GMP), FDA regulations, and 503B guidelines, along with excellent attention to detail and analytical skills.
Responsibilities
Conduct routine testing and inspection of raw materials, in-process samples, and finished products to ensure compliance with established quality standards and specifications.
Perform environmental monitoring, including sampling of air, surfaces, and personnel in cleanroom environments, ensuring adherence to GMP regulations.
Maintain accurate and detailed records of all quality control activities, including test results, deviations, and corrective actions.
Collaborate with production and quality assurance teams to investigate and resolve any quality issues or non-conformances.
Operate and maintain laboratory equipment, ensuring proper calibration and function according to standard operating procedures (SOPs).
Participate in the validation and qualification of new equipment, processes, and methods to ensure consistent quality and reliability.
Assist in the development and revision of SOPs, work instructions, and other quality-related documents.
Ensure timely and accurate completion of all required documentation and reports, maintaining compliance with FDA regulations and 503B guidelines.
Support internal and external audits by providing necessary documentation and responding to audit findings in a timely manner.
Stay current with industry trends, regulatory updates, and best practices related to quality control and 503B outsourcing facilities.
Assist in the training and mentoring of new quality control staff, ensuring adherence to company policies and procedures.
Work closely with the Quality Assurance team to implement and monitor quality improvement initiatives.
Conduct stability testing and data analysis to ensure product integrity over specified shelf life.
Physical Requirements
Must possess 20/20 vision (with or without correction) and be able to pass vision and colorblindness test
Qualifications
TRAINING
(e.g. Professional Qualifications, On-the-job Training, Education)
An equivalent combination of education, training, and experience may substitute.
High School Diploma or equivalent
College degree preferred
Exceptional attention to detail
Current Good Manufacturing Practices (cGMP) Experience Preferred
Good Documentation Practices (cGDP) experience preferred
Cleanroom experience & experience wearing Personal Protective Equipment (PPE) preferred
Excellent verbal and written communication skills
Experience with Microsoft Office Suite (Word, Excel) and ability to utilize various software programs
Strong work ethic and ability to work effectively as a team
The Quality Control Team provides critical support to the Production Team. This is a 100% on-site position. Reliable transportation and punctuality are required
Must be able to lift items repeatedly (lifting as a team for heavier items)
Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time
Must be able to wear required PPE for extended periods of time
Position requires handling of laboratory chemicals or hazardous materials
Must be able to use necessary equipment such as computers, scanners, or other technology devices as assigned
Travel
As part of your job duties, travel may be required. If applicable, you will be compensated at the current IRS mileage reimbursement rate.
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