QC Specialist

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 a QC Specialist to join our team parttime. The QC Specialist will review and approve all raw data generated from GMP batches and stability programs.

• Review changes to analytical methods.
  
• Review COAs and other required documentation to support batch release.
  
• Review stability program protocols and recommend changes i 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.
  

Requirements

• Bachelors degree in related discipline.
  
• 46 years of experience in a quality control role within the pharmaceutical industry.
  
• Experienced reviewing and approving raw data for GMP batches.
  
• Strong knowledge of quality documentation and regulatory compliance.
• Knowledge of stability programs.
  
• Ability to effectively recommend changes and improvements.
  
• Strong analytical and problem solving skills.
  
• Excellent communication skills.
  
• Detailoriented with a focus on maintaining highquality 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.
  

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.

#LIRW1

Bachelor's degree in related discipline. 4-6 years of experience in a quality control role within the pharmaceutical industry. Experienced reviewing and approving raw data for GMP batches. Strong knowledge of quality documentation and regulatory compliance. Knowledge of stability programs. Ability to effectively recommend changes 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. 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-RW1