Contract Quality Assurance Specialist

QIAGEN · Beverly

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QualityPart-timeCompany career page

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Role summary

Contract quality assurance specialist role at a life-sciences company focused on ensuring products meet regulatory standards before manufacturing or customer release. The position involves reviewing documentation, supporting product disposition, and maintaining compliance with cGMP and FDA requirements in a 25-hour-per-week, 3-month contract.

What they're looking for

Bachelor's degree in scientific discipline or equivalent professional experience
Minimum 2 years professional experience, preferably in regulated industry
Working knowledge of cGMP, QSRs, ISO standards, and FDA regulations
Strong attention to detail and auditing skills for complex documentation review
Ability to manage multiple priorities independently in fast-paced environment
Proficiency with Microsoft Office; ERP or EDMS experience advantageous

What you'll be doing

Review and audit device history records, batch records, and quality documentation for regulatory compliance
Perform product release activities and disposition decisions for materials and finished goods
Review deviations, nonconformities, and related quality records throughout product lifecycle
Partner with operations and cross-functional teams to resolve documentation issues
Identify continuous improvement opportunities for product release processes and efficiency

Compensation$30-$35/hour

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Date posted5 days ago

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