Contract Quality Assurance Specialist

QIAGEN • Beverly, MA

9d • $30 - $35 • Hybrid

About The Position

At QIAGEN, you will play a critical role in ensuring that our products meet the highest quality standards before reaching customers or progressing through the manufacturing process. As a Contract QA Specialist, you will be responsible for reviewing and auditing quality documentation, supporting product disposition activities, and helping maintain compliance with applicable regulatory requirements and quality standards. This role requires a detail-oriented professional who thrives in a regulated environment, enjoys collaborating across functions, and is passionate about continuous improvement and product quality. This role is 25 hours per week, Monday-Friday. This is a 3-month contract.

Requirements

• Bachelor's degree in a scientific discipline or equivalent scientific experience, with a minimum of 2 years of professional experience, preferably within a regulated industry.
• Working knowledge of cGMP, Quality System Regulations (QSRs), ISO standards, and other applicable regulatory requirements.
• Strong attention to detail and auditing skills, with the ability to accurately review complex documentation and data.
• Demonstrated ability to manage multiple priorities, work independently, and remain flexible in a fast-paced manufacturing environment.
• Effective communication and interpersonal skills, with the ability to collaborate and build relationships across all organizational levels.
• Proficiency with Microsoft Office applications.
• Team-oriented mindset with strong organizational skills and the ability to support demanding projects while maintaining quality and compliance standards.

Nice To Haves

• Experience with ERP systems and/or Electronic Document Management Systems (EDMS) is advantageous.

Responsibilities

• Review and audit device history records, batch records, and other quality documentation to ensure compliance with internal procedures, cGMP requirements, ISO standards, FDA regulations, and other applicable quality requirements.
• Perform product release activities and disposition decisions for materials and finished goods approved for manufacturing use or customer distribution.
• Support the control of products throughout their lifecycle, including review of deviations, nonconformities, and related quality records.
• Partner with Operations and cross-functional teams to resolve documentation issues and ensure compliance with quality requirements.
• Contribute to continuous improvement initiatives by identifying opportunities to enhance Product Release processes, procedures, and efficiency.
• Participate in departmental metric collection, analysis, and reporting to support quality objectives and operational excellence.
• Serve as a quality resource for training, cross-functional collaboration, and quality-related inquiries across the organization.

Benefits

• Bonus/Commission
• Local benefits
• Referral Program
• Volunteer Day
• Internal Academy (QIALearn)
• Employee Assistance Program
• Hybrid work (conditional to your role)
• Benefits mandated by applicable state and federal law, if any, which are provided by the agency employer.

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level