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QC Qualification Engineer
•6 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Pomona, California |
About this job
Job Description
Job Description
Requirements
Benefits
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 a motivated and detail-oriented QC Instrumentation Engineer to support the generation and execution of protocols, and ensure quality and compliance in deliverables.
- Create, review, and maintain validation and qualification documentation, including protocols, reports, and standard operating procedures (SOPs), ensuring accuracy and completeness.
- Perform qualification of QC, MFG, and TS instruments and systems.
- Generate and execute Installation, Operation, Performance Qualification, and SQ protocols following a risk-based approach strategy.
- Generate and investigate protocol exceptions.
- Generate and qualify final reports, traceability matrices, validation assessments, SOPs, periodic reviews, etc.
- Provide accurate, clear, and compliant documentation updates.
- Identify areas for process improvements and efficiency gains within the qualification and validation processes.
- Resolve issues when qualification does not meet requirements, conducting root cause analysis and identifying preventative or corrective actions required.
- Serve as liaison between client and vendors when required (instruments require vendor qualification such as IOPQ of software validation, etc).
- Attend required meetings and assist in project coordination.
- Stay current with industry regulations and best practices to ensure that validation and qualification activities are conducted in compliance with relevant standards.
- Additional responsibilities as assigned to support project completion and success.
Requirements
- 2-5 years of QC Qualification experience in the pharmaceutical industry.
- Must have experience with HPLC and Empower.
- Strong Knowledge of GMP and other industry regulations.
- Strong attention to detail and analytical skills.
- Ability to work both independently and in a team.
- Excellent communication skills, both verbal and written.
- Highly motivated with the ability to work independently, manage multiple projects, and meet deadlines.
- Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
Benefits
Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
Estimated Annual Salary (dependent on experience) $70,000 - $85,000.
Equal Opportunity Employment Statement:
PSC is committed to 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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