Senior Quality Engineer

Position Summary

The Senior Quality Engineer is responsible for leading thorough investigations into laboratory out-of-specification (OOS) results and quality incidents across internal and third-party laboratories to ensure compliance with industry regulations and internal standards.

This role involves collaboration with cross-functional teams to identify root causes, develop corrective and preventive actions (CAPA), and drive continuous improvement in laboratory quality processes.

Essential Functions

• Lead and manage OOS investigations across internal and third-party laboratories, ensuring timely, thorough, and compliant documentation of findings.
• Coordinate with third-party laboratory partners to ensure consistent investigation processes and alignment with company quality standards.
• Perform in-depth root cause analysis for OOS and other laboratory deviations, ensuring adherence to regulatory guidelines and company policies, including external laboratory testing.
• Develop and implement corrective and preventive actions (CAPA) related to investigations within both internal and third-party laboratories, ensuring effective resolution and prevention of recurrence.
• Review and update standard operating procedures (SOPs) to reflect best practices in OOS investigations, incorporating feedback from third-party laboratory interactions.
• Prepare and present detailed investigation reports to senior management, emphasizing findings from both internal and external laboratories.
• Support internal and external audits, focusing on laboratory compliance, OOS processes, and third-party laboratory oversight.
• Conduct training for internal laboratory staff and provide guidance to third-party partners on OOS investigation processes, ensuring awareness of regulatory requirements and internal standards.
• Monitor the effectiveness of implemented CAPAs across internal and third-party laboratories, adjusting strategies to achieve desired outcomes.

Education & Experience

• Bachelor’s degree in Life Sciences, Chemistry, Microbiology, or a related field, or equivalent experience.
• 5-7 years of experience in quality assurance or quality control, with a strong focus on laboratory OOS investigations, including oversight of third-party testing labs.
• Proven track record in conducting root cause analysis and managing CAPA processes within internal and external laboratory environments.
• In-depth knowledge of Good Manufacturing Practices (GMP) and regulatory requirements for laboratory investigations, including third-party laboratory compliance.

Core Competencies

• Analytical Thinking & Problem Solving
• Project Management
• Communication Proficiency
• Detail-Oriented and Process-Driven
• Leadership and Collaboration Skills

Work Environment

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is in an office environment and routinely uses standard office equipment which may include lifting up to 25 pounds for extended periods of time throughout the day.
• This position involves sitting for extended periods of time, however, may be exposed to manufacturing areas where moving mechanical parts and heavy machinery are located.

Work Schedule

• Monday-Friday, 7 : 30am-4 : 30pm (shifts may vary based on needs of the company)
• Occasional overtime may be required
• Some travel may be required

Employee Benefits :

PRL is committed to help support employees by offering company benefits.

• Paid Time Off
• Competitive Compensation
• Paid Holidays
• Healthcare insurance
• Dental and Vision insurance
• Life Insurance
• 401(K) retirement program with company match
• HSA (Healthcare spending or reimbursement account)
• Employee product discounts
• A great company culture with a teamwork attitude
• Excellent managers who really care about their staff
2 days ago