Quality Associate Engineer

Quality Associate Engineer 

Role Overview

The Quality Associate Engineer is a key contributor to the Quality Assurance team, responsible for managing  Change Management System and supporting manufacturing and testing activities in compliance with cGMP regulations. This role partners closely with cross-functional teams to ensure changes are properly assessed, documented, and implemented while maintaining the highest quality standards.

Key Responsibilities

• Author and maintain change control records to support Quality Assurance activities.
• Develop impact assessments, risk analyses, and change action plans in collaboration with QA and cross-functional partners.
• Track and manage the status of change controls to ensure timely execution and closure.
• Participate in Change Control Review Board meetings and document meeting minutes.
• Support senior engineers with the implementation of new or modified systems.
• Review and approve calibration and preventive maintenance records for manufacturing equipment, analytical instruments, facilities, and critical utilities.
• Collaborate with cross-functional teams to ensure accurate and timely review of reports and records in accordance with established SOPs.
• Evaluate and approve calibration out-of-tolerance events, including participating in investigations to assess potential product impact.
• Author, review, and revise quality system SOPs and forms to support continuous improvement.
• Support regulatory inspections and quality audits as needed.
• Communicate potential quality or regulatory risks to Quality Management in a timely manner.
• Perform other related duties as assigned.

Minimum Qualifications

• Bachelor of Science degree in Biology, Chemistry, Biochemistry, or a related scientific discipline.
• Minimum of 2 years of experience in the pharmaceutical or biopharmaceutical industry.
• Prior experience in Quality Engineering preferred.
• Working knowledge of FDA cGMP regulations, ICH guidelines, and quality compliance standards.
• Strong interpersonal and collaboration skills with the ability to work effectively in a team environment.
• Flexibility in work schedule to meet business needs.

Physical Demands & Work Environment

• Occasional exposure to electrical hazards, chemicals, vibrations, fumes, wet or humid conditions, and moving mechanical parts.
• Noise levels may occasionally be loud.
• Ability to sit, stand, walk, and use hands for handling and reaching.
• Occasional climbing, balancing, stooping, kneeling, crouching, or crawling.
• Regular lifting up to 10 pounds; occasional lifting up to 20 pounds.
• Vision requirements include close, distance, and color vision.
• Reasonable accommodations may be made to enable individuals to perform essential job functions.

Who You Are

• A positive, team-oriented professional with a proactive, “can-do” mindset.
• A clear and confident communicator, both verbally and in writing.
• Highly organized with strong multitasking abilities and exceptional attention to detail.
• Skilled at building strong working relationships across teams and with external partners.

Salary Range: $55K to $72K annually, based on experience and qualifications.
 We also provide opportunities for professional growth in a supportive and inclusive work environment.

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