Quality Control Associate

SUMMARY: The Quality Control (QC) Associate I will contribute to general QC operation and testing in support of current Good Manufacturing Practice (cGMP) manufacturing. The individual will participate in Environmental Monitoring (EM), raw material, intermediates, drug product and stability testing program.

DUTIES AND RESPONSIBILITIES: • Perform raw material inspection and sampling. • Perform EM sampling in aseptic manufacturing environments: total particulate monitoring, active air sampling, surface and personnel monitoring. • Assist with submission of samples to contract testing laboratories. • Assist with organizing QC laboratories including equipment calibration. • Conduct QC tests for raw material, intermediates, drug product and stability samples. • Perform test following test protocols and procedures in compliance with quality standards and cGMP regulations applicable to QC laboratory. • Deliver cGMP compliant testing data and reports. • Participate in investigation of deviation or out-of-specification results in QC laboratory.

EDUCATION AND EXPERIENCE: • B.S. Degree in Biology, Cell Biology, Microbiology, Molecular Biology or Biochemistry. • Experience working in a laboratory (academic or industry) setting and within a cGMP regulated environment is preferred.

JOB SPECIFICATIONS: • Attention to detail and organizational skills: Exceptional ability to manage tasks efficiently and maintain high levels of accuracy. • Proficiency in Microsoft software: Demonstrated experience with Microsoft Office Suite and other Microsoft applications. • Initiative in a dynamic environment: Strong self-starter with the ability to thrive in a fastpaced setting. • Teamwork and independence: Capable of collaborating effectively within a team and working independently after initial training. • Communication skills: Excellent written and verbal communication abilities. • Flexibility: Willingness to work flexible hours, including occasional weekends, to support production needs. • Knowledge of GMP Regulations: Basic familiarity with Good Manufacturing Practices (GMP) and industry standards

WORKING CONDITIONS Office and Lab environment. While performing the duties of this Job, the employee is frequently exposed to toxic or caustic chemicals. This is an indoor position requiring the ability to perform experiments in the laboratory, and type and use a computer. May work in Cleanroom for an extended period of time. PHYSICAL DEMANDS While performing the responsibilities of the job, the employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch, or crawl. The physical effort required is sedentary, lifting up to 10 pounds. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal. These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.