QA Associate
Irvine, California, United States of America
Full Time
7 hours ago
$85,000 - $115,000 USD
Key skills
CommunicationCollaboration
About this role
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your 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.
- 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.
Benefits
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. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement
PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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