Specialist, QA Quality Systems and Distribution (Senior) - Quality Assurance and Regulatory Compliance in Life Sciences
Join the Team: Specialist, QA Quality Systems and Distribution (Senior)
Are you a motivated and detail-oriented professional looking for a challenging role in the life sciences industry? Do you have a passion for quality assurance and regulatory compliance? Look no further! We are seeking a highly skilled and experienced Specialist, QA Quality Systems and Distribution (Senior) to join our team in Norwood, Massachusetts. This position offers a unique opportunity to work in a dynamic and fast-paced environment, utilizing your skills and expertise to drive success in the life sciences arena.
About Us
As a leading staffing and recruitment agency in the world, we specialize in connecting top talent with prestigious life sciences and biopharma companies. Our team of experts has a deep understanding of the industry and a proven track record of finding the perfect role for candidates like you. By partnering with us, you gain access to a large network of top employers and detailed information about hundreds of positions, allowing you to take control of your career and make a meaningful impact in the lives of others.
Job Summary
This contract position is based in Norwood, Massachusetts, and offers a competitive salary of $35.00 - $47.01 per hour. As a Specialist, QA Quality Systems and Distribution (Senior), you will play a critical role in ensuring the quality and compliance of our distribution processes. You will work closely with cross-functional teams to drive success and achieve business goals. This is a unique opportunity to join a team that values innovation, collaboration, and employee growth.
Key Responsibilities:
- Perform release process confirmation for CMO batches, including Veeva documentation checks and SAP release steps
- Conduct batch record review as needed to ensure compliance with regulatory requirements
- Provide administration support for documentation archive in Veeva eQMS
- Ensure compliance with required training and resolve issues with CMO documentation in collaboration with CS leads and CMO leads
- Rotate to support Compliance, operational excellence project work, and/or quality project management teams, depending on skill set and previous experience
Essential Qualifications:
- Senior Specialist level with 5+ years of experience in quality assurance and regulatory compliance
- Excellent communication skills, with the ability to effectively collaborate with cross-functional teams
- Proficiency in regulatory requirements, including GMP and FDA regulations
- Familiarity with Veeva systems or similar quality document management systems
- Experience performing batch record review and batch disposition
- Familiarity with Drug Product GMP Manufacturing
Preferred Qualifications:
- Experience working in a life sciences or biopharma company
- Knowledge of quality assurance and regulatory compliance principles
- Certifications in quality assurance or regulatory compliance (e.g., CQA, CQP)
Skills and Competencies:
- Quality assurance and regulatory compliance
- GMP (Good Manufacturing Practice)
- Veeva systems or similar quality document management systems
- Batch record review and batch disposition
- Drug Product GMP Manufacturing
- Excellent communication and collaboration skills
- Ability to work in a fast-paced environment and prioritize tasks effectively
Career Growth Opportunities and Learning Benefits
At Randstad, we are committed to helping our employees grow and develop their skills. This position offers a unique opportunity to work on challenging projects, collaborate with cross-functional teams, and contribute to the success of our clients. You will have access to training and development programs, mentorship opportunities, and a comprehensive benefits package, including:
- Health insurance
- Incentive and recognition program
- 401K contribution (based on eligibility)
Work Environment and Company Culture
Our Norwood, Massachusetts office offers a dynamic and collaborative work environment, with a team of experienced professionals who are passionate about quality assurance and regulatory compliance. We value innovation, teamwork, and employee growth, and strive to create a workplace that is inclusive, diverse, and fun. This position offers a hybrid work model, combining remote work with time in our office.
Compensation and Benefits
The salary for this position is set at a competitive rate of $35.00 - $47.01 per hour, depending on experience. In addition to a comprehensive benefits package, we offer:
- Paid time off
- Holiday pay
- Flexible work arrangements
Equal Opportunity Employer
Randstad is an equal opportunity employer, committed to diversity and inclusion. We welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].
How to Apply
If you are a motivated and detail-oriented professional looking for a challenging role in the life sciences industry, we encourage you to apply for this exciting opportunity. Please submit your application today, and take the first step towards a rewarding career in quality assurance and regulatory compliance.
Don't Hesitate, Apply!
Don't worry if you don't meet every single requirement. We value a great attitude and a willingness to learn above all. Submit your application today, and join our team of passionate professionals who are making a difference in the lives of others.
Apply for this job