Quality Systems Specialist
Quality Systems Specialist
نُشرت في :
25-10-2023
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1 وظيفة شاغرة
نُشرت في :
25-10-2023
الوصف الوظيفي
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 an experienced and analytical Quality Systems Specialist. Successful candidates will have strong knowledge of business processes regarding quality management systems, documentation, data analysis, deviations, and corrective and preventative actions, with a deep understanding of workflows to be able to provide technical and workflow support to key stakeholders. This position will play a critical role in ensuring the integrity and effectiveness of our quality management systems.
- Maintain the QMS to ensure compliance with regulatory requirements and industry standards.
- Collaborate with cross-functional teams to implement and improve quality processes.
- Support the investigation and resolution of deviations, CAPAs, and change controls.
- Provide guidance on the development and implementation of effective corrective and preventive actions.
- Review and approve quality-related documents, ensuring accuracy and compliance.
- Provide technical support and expertise to users, addressing questions and issues related to workflows and system functionalities.
- Identify opportunities for process improvement and efficiency gains within the quality management systems.
- Conduct data analysis to identify trends, patterns, and areas for improvement. Generate reports and metrics to communicate the performance of quality management systems.
- Ensure that audit findings are documented, communicated, and addressed in a timely manner.
- Collaborate with stakeholders to implement enhancements and drive continuous improvement initiatives.
- Additional responsibilities as required.
Requirements
- Bachelors Degree in relevant field.
- 5+ years of experience in a quality systems role within the pharmaceutical industry.
- Excellent understanding of business processes and workflows.
- Advanced knowledge of business processes as related to deviations, corrective and preventative actions, and change controls.
- Strong data analysis skills to be able to identify trends, patterns, and areas for improvement.
- Experience with report generation and trend tracking.
- Experience and good knowledge of audit processes.
- Demonstrated ability to provide technical support and training to users.
- Advanced understanding of regulatory requirements.
- Experience with Veeva QMS is a plus.
- Strong analytical and problem-solving skills.
- Effective communication and interpersonal skills.
- Travel is required. 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.
Benefits
Offering a full suite of benefits, PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
Estimated Annual Salary (dependent on experience) $100,000 - $145,000.
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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Bachelor's Degree in relevant field. 5+ years of experience in a quality systems role within the pharmaceutical industry. Excellent understanding of business processes and workflows. Advanced knowledge of business processes as related to deviations, corrective and preventative actions, and change controls. Strong data analysis skills to be able to identify trends, patterns, and areas for improvement. Experience with report generation and trend tracking. Experience and good knowledge of audit processes. Demonstrated ability to provide technical support and training to users. Advanced understanding of regulatory requirements. Experience with Veeva QMS is a plus. Strong analytical and problem-solving skills. Effective communication and interpersonal skills. Travel is required. 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.
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