Product Quality Assurance Associate

Job Summary

Responsible for the initiation and completion of lot logs, adding C of As to the indicated location, review of production paperwork as required. Performs all tasks in compliance to the company's quality system requirements.

Key Duties

Tasks/Duties/Responsibilities:

• Initiate and complete Lot Release logs in Master Control
• Ensure all Lot Release records are appropriately stored, maintained and retrievable.
• Ensure all good documentation practices are always adhered to.
• Maintain complete, thorough and timely documentation.
• Interact cooperatively with team members at all levels and receive instruction well from all senior staff
• Participate in the review of production records, work instructions or other quality records to ensure products made available for distribution meet predetermined formulation, inspection requirements and testing requirements
• Other duties as assigned

Other Duties/Physical Requirements

• Physical
  • Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.
  • Ability to sit for long periods of time, bend, reach and twist through the course of the workday.
• Other
  • Must be able to adhere to applicable safety practices when on the manufacturing floor or in laboratories.
  • Ability to analyze, concentrate and review paperwork for long periods of time in an open work environment.
  • Ability to work on a computer including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.

Qualifications

Minimum Education or Equivalent Experience Required/Preferred

• Bachelor's degree in Biology, Biochemistry or Microbiology is preferred or equivalent experience in a related industry.
• Previous experience in document review and/or manufacture of diagnostics kits is preferred, but not required.

Competencies Required or Preferred

• Ability to read, understand and follow all company SOPs and Guidelines
• Computer proficiency (Word and Excel)
• Excellent interpersonal, organizational, written and oral communication skills.
• Must be well organized and can meet strict deadlines and perform under pressure in a fast-paced environment
• Must be able to work independently as well as collaboratively in a team setting with peers and other departments in a cross functional setting
• Must be a self-starter, detail oriented and able to prioritize and balance both workload and timelines

Required Travel %

• <5%