Job Description

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 to form something truly special. When you decide 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 QA Investigator. This is a W2 temp 3-6 month position with potential extension.

• Conduct detailed investigations into quality incidents, deviations, and non-conformances, ensuring all investigations are appropriately documented. 
• Effciently identify root-causes, analyzing trends and data to prevent reoccurrence. 
  
• Identify and implement recommendations for improvement. 
  
• Collaborate with cross-functional teams to gather necessary information and data.
• Develop and implement effective CAPAs based on investigation findings. Monitor the effectiveness of CAPAs and make adjustments as needed.
• Generate and maintain accurate and up-to-date documentation in accordance with Good Manufacturing Practices (GMP). Ensure all documentation and reporting accurately includes incidents, root cause, preventative action, impact, etc. 
  
• Provide internal and external audit support as needed. 
  
• Ensure production and project schedules are on track. 
  
• Continuously monitor manufacturing processes, activities, and systems to ensure compliance with industry regulations, cGMPs, and internal standard operating procedures. 
  
• Assist in internal and external audits by providing investigation reports and documentation.
  
• Additional responsibilities as required.
  

Requirements

• Bachelor's degree in related engineering/manufacturing/scientific discipline. 
  
• 2-5 years of experience in quality role within the pharmaceutical manufacturing industry. 
  
• Strong understanding of cGMP and industry regulations/quality requirements. 
  
• Excellent technical writing skills and understanding of quality documentation in order to generate, review, and approve required documentation.
  
• Experienced documenting and reporting investigation findings. 
  
• Strong attention to detail and commitment to quality. 
  
• Advanced analytical and problem solving skills.
  
• Excellent communication and interpersonal skills. 

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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