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Quality Assurance Csv Engineer

Company

PSC Biotech
Address ,
Employment type
Salary
Expires 2023-09-17
Posted at 8 months ago
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 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


  • Provide QA review and approval for change control records.
  • Review and evaluate computer systems documentation, including system design, functional specifications, and test plans, to ensure compliance with regulations and internal quality standards.
  • Provide quality assurance services for computer system validation projects.
  • Collaborate with cross functional teams to define requirements and specifications for computer systems validation.
  • Provide QA review and approval for computer system validation.
  • Perform risk assessments and impact analyses to identify critical areas for computer systems validation and determine the validation approach.
  • Develop and execute computer systems validation strategies and protocols in accordance with industry regulations and internal quality standards.
  • Other duties as assigned.



Requirements

  • Veeva experience is a plus.
  • Bachelor’s degree in engineering or related.
  • Excellent analytical and problem solving skills.
  • Excellent communication skills, both verbal and written.
  • Strong attention to detail.
  • 3+ years of Computer System Validation (CSV) experience and at least 1 year of Quality Assurance experience.
  • Strong understanding of cGMPs and industry quality standards and regulations.
  • Excellent organization skills and ability to prioritize tasks and drive project completion.
  • While this is a remote position, 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.
  • Strong technical writing skills.



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.


  • 401(k) and 401(k) matching
  • Education Assistance
  • Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
  • Financial Perks and Discounts
  • Pet Insurance
  • Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  • Discounted rate at Anytime Fitness
  • PTO, Sick Time, and Paid Holidays



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.

#LI-AK1

Bachelor’s degree in engineering or related. 3+ years of Computer System Validation (CSV) experience and at least 1 year of Quality Assurance experience. Veeva experience is a plus. Strong technical writing skills. Strong understanding of cGMPs and industry quality standards and regulations. Excellent communication skills, both verbal and written. Excellent analytical and problem solving skills. Excellent organization skills and ability to prioritize tasks and drive project completion. Strong attention to detail. While this is a remote position, 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.