Rockville, United States | Posted on 03/04/2025
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 seeking a highly skilled and detail-oriented Quality Assurance Engineer to join our team in the life science sector. The ideal candidate will have a strong background in quality assurance processes, with specialized experience in auditing, ensuring compliance with regulatory standards, and maintaining the highest quality standards in pharmaceutical production. This individual will play a crucial role in the review and assessment of manufacturing practices, quality control systems, and regulatory compliance within a highly regulated environment.
- Develop, implement, and maintain quality assurance processes and procedures in alignment with industry standards and regulations.
- Ensure all manufacturing processes comply with relevant regulations, including but not limited to FDA, EMA, ICH, and GMP guidelines.
- Review batch records, validation documentation, and quality control data to ensure compliance and product quality.
- Conduct internal and external audits to assess compliance with Good Manufacturing Practices (GMP), FDA regulations, and other relevant standards.
- Collaborate with cross-functional teams to ensure effective implementation of audit findings and continuous improvement initiatives.
- Prepare detailed audit reports, CAPA (Corrective and Preventive Actions) reports, and other documentation as required.
- Maintain thorough and accurate records of quality assurance activities, audits, and regulatory communications.
- Participate in the preparation and review of SOPs, work instructions, and other quality-related documents.
- Lead or participate in continuous improvement initiatives, focusing on quality and operational efficiency.
Requirements
- Bachelor's degree in engineering or related technical field.
- Minimum of 5-7 years of experience in quality assurance within the life science industry.
- Proven experience in conducting GMP audits, both internal and external, in a pharmaceutical or life sciences environment.
- Experience with regulatory bodies such as the FDA, EMA, and other international regulatory agencies.
- Familiarity with Quality Management Systems (QMS), CAPA, deviation management, and risk management.
- Strong understanding of GMP regulations, FDA guidelines, and other applicable industry standards.
- Excellent analytical and problem-solving skills.
- Exceptional attention to detail and ability to identify potential areas of risk and non-compliance.
- Strong verbal and written communication skills, with the ability to prepare clear and concise reports.
- Travel is required; candidates must be willing and able to travel as needed for project assignments and client engagements.
PSC 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.