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Location

Pomona, CA | United States

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Job description

This is a remote position.

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 multicultural 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 Quality Engineers with expertise in Corrective and Preventative Action Quality Systems. This is a remote position supporting Central Time Zone.

• Provide subject matter expertise for CAPA Quality Systems and lead overall CAPA strategy and implementation.
• Perform thorough root cause investigation for required IT system procedures and specifications.
• Maintain accurate and uptodate documentation related to CAPA activities.
  
• Develop approve and document all investigations for exceptions nonconformities deviations and so on. This also includes resolution implementation effectiveness checks etc.
• Develop teams to effectively handle all CAPA events and ensure team members efficiently meet all tasks and deliverables.
• Monitor the implementation plan and track effectiveness check schedules to drive ontime project success.
• Adhere to all industry and internal regulations and procedures. Stay abreast of industry regulations and standards ensuring that the CAPA quality system remains compliant with applicable requirements.
• Additional responsibilities as required.
  

Requirements

• Proven Quality Engineering background.
• At least 2 years of experience developing and approving CAPA documentation in the pharmaceutical industry.
• Advanced knowledge of full life cycle CAPA processes from start to finish.
• Strong understanding of regulatory requirements.
• Proven experience in leading crossfunctional teams and driving continuous improvement initiatives.
• Excellent communication interpersonal and leadership skills.
• Excellent technical writing skills.
• Strong analytical and problem solving skills.
• Experienced in various investigation tools.
• TrackWise experience is a plus.
• Strong time management and organizational skills with the ability to coordinate multidepartmental tasks and deliverables.
• 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
  

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 employersponsored 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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