QA Associate

About the Role

We are seeking a QA Associate to support calibration and maintenance activities within a regulated life sciences manufacturing environment. This individual will be responsible for performing equipment calibrations, supporting the closure of calibration-related out-of-tolerance (OOT) events, and ensuring instrumentation remains compliant with internal procedures and regulatory requirements. This is a 3-month, contracted role with potential extension based on performance. No sponsorship available.

Responsibilities

• Perform routine, preventive, and corrective calibrations on manufacturing, laboratory, and utility instrumentation.
• Troubleshoot calibration discrepancies and support resolution of out-of-tolerance (OOT) events.
• Execute calibration activities in accordance with established procedures, quality standards, and regulatory requirements.
• Review calibration records and documentation for accuracy, completeness, and compliance.
• Support the investigation, documentation, and closure of calibration-related deviations using Veeva.
• Utilize Blue Mountain CMMS to manage calibration schedules, work orders, and calibration records.
• Coordinate with Manufacturing, Quality, Engineering, and Validation teams to minimize equipment downtime and ensure timely completion of calibration activities.
• Maintain calibration standards, tools, and test equipment in a compliant state.
• Identify and escalate equipment performance concerns that may impact product quality or operational efficiency.
• Support audit readiness activities by ensuring calibration documentation is complete and inspection ready.
• Assist with continuous improvement initiatives related to calibration processes and instrumentation reliability.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Electronics, Instrumentation, or a related technical field is preferred; equivalent hands-on experience will also be considered.
• 3–7 years of experience performing instrument and equipment calibrations in a GMP-regulated pharmaceutical, biotechnology, medical device, or related environment.
• Experience investigating and closing calibration-related out-of-tolerance (OOT) events.
• Proficiency with Blue Mountain CMMS for calibration management.
• Experience using Veeva for deviation management and quality documentation.
• Working knowledge of GMP, FDA, and industry regulatory requirements related to calibration and maintenance activities.
• Ability to read and interpret technical drawings, equipment manuals, and calibration procedures.
• Strong attention to detail, documentation, and problem-solving skills.
• Excellent communication and cross-functional collaboration abilities.
• Ability to manage multiple priorities in a fast-paced environment.
• Must be authorized to work in the U.S.
• No C2C at this time.

Pay

The salary bracket for this role is set between $85,000 - $115,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.