QC Specialist

Job Description

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 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 multiple QC Specialists to join our team. The QC Specialists will be responsible for ensuring the quality and compliance of pharmaceutical products through analytical testing, documentation, and collaboration with cross-functional teams. These roles play a key part in product release, regulatory compliance, and continuous improvement initiatives.

• Review changes to analytical methods.
  
• Review COA's and other required documentation to support batch release.
  
• Review stability program protocols and recommend changes as needed.
  
• Review reference standard documentation.
  
• Participate in meetings with CDMOs as needed.
  
• Assist with annual reports and answers to the FDA.
  
• Additional responsibilities as required.
  

• Bachelor's degree in related discipline.
  
• 5+ years of experience in a quality control role within the pharmaceutical industry.
  
• Experienced reviewing and approving documentation and data.
  
• Strong knowledge of quality documentation and regulatory compliance.
• Knowledge in OOX Triaging.
  
• Experienced in testing support.
  
• Ability to recommend changes effectively and improvements.
  
• Strong analytical and problem solving skills.
  
• Excellent communication skills.
  
• Detail-oriented with a focus on maintaining high-quality standards.
  
• 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.
  
• Must be authorized to work in the US.
  
• No C2C at this time.
  

W2 Temp positions include our medical and sick time benefits.

Adhering to the requirements of New Jersey's law on salary transparency, the salary bracket for this role is set between $60,000 - $130,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

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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