Quality Assurance Associate

Overview

The Quality Assurance Associate role is to handle market complaints and oversee quality in our facilities (warehouses and production plants, etc.) including Quality Control activities.

$50,000.00/yr - $60,000.00/yr

NY, NJ, PA, MD, and DE

• Document, investigate, and participate in market complaints received from customers.
• Prepare market complaint investigations with scientifically sound write‑ups through coordination with different departments and stakeholders.
• Write appropriate responses to customers as needed addressing their concerns.
• Prepare trend reports for market complaints received from customers.
• SOP/Training:
  Write, revise, and provide training to new and existing employees for Standard Operating Procedures, testing specifications, protocols, and reports as needed.
• Manage training software, enter training records, and trend all employees’ training.
• Production/Warehousing:
  • Inspect procedures and logbooks to ensure they are efficient and comply with regulations.
  • Assist in monthly internal audits.
  • Record all data and results in specified forms, records, or log books with accuracy.
  • Assist in reviewing and ensuring all completed manufacturing records are free from error before product release.
  • Assist in product release activities after thorough review of testing data and batch manufacturing records.
  • Assist in internal and external audits with management guidance.
  • Ensure and maintain retained samples.
  • Pull samples.
  • Oversee and inspect production lines throughout production runs.
  • Test and monitor the facility environments for microbial contaminants.
  • Water system, air monitoring, drains, hoses and sinks.
  • Inspect, test, and release cleaned equipment.
  • Work closely with sanitation personnel.
  • Maintain the trending data/results generated from the environmental monitoring and cleaning equipment verifications.
  • Send raw materials, components, finished products, and stability samples to appropriate 3rd party laboratories.
  • Maintain a clean working environment.
  • Assist with filing of QC and QA documents.
  • Assist with cleaning/method validation studies.
  • Support in handling and disposing of product returns.
  • Discover opportunities for continuous improvement.
  • Participate in other duties as assigned by the Quality management.

• Associate’s degree in science‑related field.
• 3‑5 years experience in a QA role at an FDA‑regulated Pharmaceutical, Nutraceuticals, or Food industry company.
• Critical thinking and ability to write market complaint investigations.
• Basic knowledge of Microsoft Office.
• Ability to work closely with co‑workers.
• Effective communication and organizational skills.
• Strong problem‑solving/troubleshooting skills.
• Ability to multi‑task in a fast‑paced environment.
• Ability to travel at least 20% of the time.

• 401(k)
• 401(k) matching
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance