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 is a 3-month, contracted role with potential extension based on performance.

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.
• Cookordination 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.
• Aid in 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.

Qualifications

• Must be authorized to work in the U.S.

Skills

• Technical proficiency with Blue Mountain CMMS and VeeVa.
• Understanding of GMP, FDA, and industry regulatory requirements.
• Strong attention to detail and problem-solving skills.
• Effective communication and collaboration abilities.

Benefits

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