What are the responsibilities and job description for the Quality Assurance Manager position at Harba Solutions Inc.?
Job Responsibilities
- Oversee quality support for manufacturing operations, ensuring proper staffing and seamless integration of quality oversight throughout production activities.
- Supervise batch record reviews and ensure timely identification and resolution of documentation issues during manufacturing processes.
- Guide and develop team members on core quality practices including sterile operations, gowning procedures, cleanliness standards, and equipment readiness.
- Collaborate cross-functionally to align quality activities with production timelines while maintaining rigorous quality expectations.
- Implement clearance procedures to support start-up and shutdown of critical production spaces, ensuring readiness for each phase of operations.
- Lead investigations into deviations and product quality issues, applying structured problem-solving tools and driving sustainable corrective actions.
- Reinforce a culture of compliance through routine observation, coaching, and engagement with safety and operational teams.
- Ensure data accuracy and compliance by managing documentation workflows and contributing to the maintenance of internal quality systems.
- Stay informed on current trends in quality assurance and regulatory expectations to inform ongoing improvements and ensure sustained compliance.
Qualifications
- Bachelor’s degree in a life science, engineering, or related technical field.
- 8 years of experience in a QA role within a regulated manufacturing or production environment.
- Minimum of 5 years in a leadership or supervisory capacity overseeing quality or compliance-focused teams.
- Deep understanding of sterile production principles, contamination control, and risk-based quality decision-making.
- Strong working knowledge of industry regulations and experience implementing quality systems and process controls.
- Proficient in reviewing documentation, supporting investigations, and utilizing digital tools for recordkeeping and data analysis.
- Skilled in coaching, team development, and cross-functional collaboration.
Salary : $100,000 - $120,000
