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 hiring an experienced Quality Engineer to join our team! The Quality Engineer will provide hands-on support for GMP investigation activities related to calibration Out-of-Tolerance (OOT) events for process and utility instrumentation. This role will focus on root cause investigations, documentation, and CAPA development while supporting broader quality engineering activities in alignment with FDA and GMP requirements.
Lead and support investigations associated with calibration Out-of-Tolerance (OOT) events for GMP-critical instrumentation.
Perform root cause analysis and document investigations in accordance with established quality systems and regulatory expectations.
Develop, document, and support corrective and preventive actions (CAPA) resulting from OOT events and related deviations.
Assess product and process impact related to instrument performance and calibration events.
Coordinate closely with instrument owners, engineering, metrology, and quality stakeholders to obtain relevant data and drive timely investigation closure.
Support remediation of investigation backlogs and ensure adherence to site timelines and quality standards.
Review and ensure compliance of quality documentation, including deviations, investigations, and CAPAs.
Apply sound quality engineering judgment to ensure compliance with GMP, FDA, and applicable regulatory guidelines.
Contribute to continuous improvement initiatives related to investigation processes, documentation quality, and compliance practices.
Support other quality engineering activities as needed, including audits, trend analysis, and quality system improvements.
Requirements
Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
5–8 years of experience in Quality Engineering, with a strong focus on investigations and CAPA within a GMP-regulated environment.
Demonstrated experience leading or supporting calibration OOT investigations and root cause analysis.
Solid understanding of GMP regulations, FDA expectations, and quality systems.
Experience working with regulated instrumentation and calibration-related documentation preferred.
Strong technical writing skills with the ability to document investigations and quality records clearly.
Ability to work independently, manage multiple priorities, and meet aggressive timelines.
Strong communication and collaboration skills, with experience working cross-functionally.
Ability to support onsite activities as required, particularly during initial project phases.
Must be authorized to work in the U.S
No C2C at this time.
Benefits
W2 temp roles include our medical and sick time benefits.
Adhering to the requirements of California's law on pay transparency, the hourly bracket for this role is set between $50 - $70. The rate 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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