What are the responsibilities and job description for the Quality Engineer position at PSC Biotech?
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 excited to accept applications for future opportunities. Join our talent pool for future openings by applying now. This is a W2Temp 6month role with potential FTE extension.We are seeking a highly skilled and detailoriented 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 crossfunctional 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 qualityrelated documents.
- Lead or participate in continuous improvement initiatives focusing on quality and operational efficiency.
Requirements
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
Key Skills
APQP,Quality Assurance,Six Sigma,ISO 9001,PPAP,Minitab,Root cause Analysis,ISO 13485,Quality Systems,Quality Management,As9100,Manufacturing
Employment Type : Full Time
Experience : years
Vacancy : 1
Monthly Salary Salary : $ 70 - 85
Salary : $70 - $85
