Quality Assurance Associate

Position Summary

The position will perform general QA activities using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations. Works on problems of a diverse scope where problem solving is required. Receives general oversight and guidance on approaches to complete project related tasks. The ideal candidate will apply skilled problem-solving abilities under general supervision to ensure continuous adherence to current Good Manufacturing Practices (cGMP).

Key Responsibilities

• Manufacturing & Shop-Floor Support: Conduct on-the-floor batch record reviews, visual equipment inspections, equipment releases, status tagging, work order reviews, and room/utility checklist verifications.
• Compliance & Monitoring: Monitor cGMP compliance throughout the facility and product lifecycle; partner with plant personnel to enforce compliance standards.
• Investigation & Corrective Actions: Follow up on preventive and corrective actions (CAPA) related to deviations, laboratory investigations, and environmental excursions.
• Documentation: Review logbooks, facility records, and production documents for accuracy and completeness.
• Operational Flexibility: Provide backup coverage for other Quality Assurance roles as needed.

Qualifications & Requirements

• Education & Experience:
  • Bachelor’s degree in a scientific discipline (or equivalent experience). Relevant pharmaceutical industry experience may be substituted for a degree.
  • Minimum of 1 year of Quality Assurance experience in the pharmaceutical industry preferred.
• Technical Skills & Knowledge:
  • Working knowledge of US Drug Product cGMP regulations and industry guidelines.
  • Experience with quality systems administration in drug product manufacturing and quality control environments.
  • Strong written, verbal communication, and computer skills.
• Physical & On-Site Requirements:
  • Ability to wear aseptic gowning and Powered Air-Purifying Respirator (PAPR) equipment for up to 4 consecutive hours.
  • Must successfully pass required health assessments prior to the start date.
  • Must pass all post-training assessments and certifications.

Key Competencies

• High attention to detail, organization, and problem-solving initiative.
• Ability to prioritize and manage multiple open issues simultaneously in a fast-paced environment.
• Strong work ethic, dependability, and a collaborative, team-oriented mindset.

Pay

$24 – $26/ hour

Schedule

Monday-Friday 1st shift