Job Title: Senior QC Associate

Work Location: Cumberland County, New Jersey

Summary:

• Support Quality Control departments in duties including but not limited to:
• Conduct Analysis in compliance with cGMP requirements, compendia standards, and internal procedures. Performs Dietary supplement analysis to support manufacturing which includes instrumental and physical testing.
• Maintain accurate record of analysis and perform documentation to company standards. Perform laboratory analysis right the first time, and document the results contemporaneously.
• Notify the manager immediately of nonconforming data or unexpected occurrences.
• Reviews and analyzes the stability samples and associated analytical data, prepares or assists in preparing Stability Summary Reports.
• Reviews/Checks of analytical data by following test methods/SOPs.
• Conducts laboratory investigation under the supervision of laboratory management.
• Organize work schedule to complete assigned tasks efficiently and on schedule.
• Ensures the laboratory is kept in a safe working environment and compliance with OSHA and other laboratory safety standards.
• Ensure and maintain retained samples.
  • Pulling of samples.
  • Organization of retaining cages.
• Oversight and Inspect production lines throughout the production run.
  • Helping to eliminate errors/ Line Clearance
• Test and monitor the facility's environment for microbial contaminants.
  • Water system, Air monitoring, Drains, Hoses and Sinks,
• Inspect, test, and release cleaned equipment
  • Working closely with sanitation personnel
• Maintain the trending of data/results generated from the environmental monitoring and cleaning equipment verifications.
• Maintain laboratory equipment and assist in ordering laboratory supplies.
  • Reagents, Microbiology media, Lab utensils, etc.
• Testing of raw materials, components, finished products, and stability.
  • Send appropriate samples to 3^rd party laboratories.
• Ensure lab testing is being conducted properly.
  • Statistical sampling plans.
• Update laboratory reagents/chemicals list as needed.
• Write and revise Standard Operating Procedures, testing specifications, protocols, and reports as needed.
• Record all data and results in specified forms, record books or log books with accuracy.
• Assist with filing documents.
• Assist with cleaning/method validation studies.
• Locate opportunities for continuous improvement.
• Other duties as assigned by Quality Management.
• Travel required: approximately 10% between different locations.

Qualifications:

• Associate’s degree in science-related field
• 2-5 years experience in FDA-regulated Pharmaceutical, Nutraceuticals or the Food industry
• Basic knowledge of Microsoft Office
• Keen eye for detail
• Ability to work closely with co-workers
• Effective communication skills
• Strong problem-solving/troubleshooting skills
• Ability to multi-task in a fast-paced environment
• Organizational skills

Published Category: Quality & Validation