Quality Assurance Specialist I

Job Overview

The Quality Assurance Specialist I is responsible for ensuring raw materials are accompanied by the appropriate documentation, releasing raw materials, intermediates, packaging, and labeling materials, and ensuring the final products meet quality standards.  

This is NOT a Regulatory role but in Quality Assurance and is an ENTRY-LEVEL role. 

**Direct Applicants ONLY - No Staffing Agencies or Third-Party Recruiters."

Role & Responsibilities

• Ensures that the product manufactured meets or exceeds customer and regulatory expectations. 

• Works in conjunction with the Quality team and management to maintain a quality management system that complies with the requirements of the current standard. 

• Maintain vendor files with applicable documents. 

• Review batch records and other relevant documents 

• Release and rejection of materials, intermediates, packaging, and labeling materials, as applicable 

• Review In-process forms, protocols, and records for adherence to Good Documentation Practices (GDP). 

• Collect and organize the Certificate of Analysis (CoA)s and Safety Data Sheet (SDS) from vendors. 

• Communicate with vendors as needed to obtain the necessary documentation for incoming materials.   

• Generate CoAs, BSE/TSE statements, and other documents for BBP final products as needed. 

• Provide the quality document to the customer upon request.  

• Assist in the management of eQMS. 

• Assist in maintaining the Quality Records and production documentation within eQMS.  

• Assist in records control of QMS and production documentation.  

• Assist in qualifying and approving the prospective vendor.  

• Assist in drafting and updates of QMS documentation as needed. 

• Assist in maintaining the Quality Records and production documentation within eQMS.  

• Assist in additional duties delegated from Quality leads

Qualifications & Requirements

• Associate's or Bachelor's degree in a scientific discipline 
• 1-3 years experience within life science & biotech industry
  
• Ability to follow instructions precisely, recognize deviations, and recommend corrective action within the scope of training. 
• Familiar with ISO 13485 and GMP  

• Have strong written and verbal communication skills, a detail-oriented work ethic, and the ability to understand recognized regulations such as ISO and GMP.  

• Ability to troubleshoot within the scope of training. 

• Ability to work independently with adherence to quality, production, and customer expectations and timelines. 

• Computer literate and experienced with Microsoft Office. Demonstrated skills in developing and organizing systems for the management of information. 

• Demonstrated ability to meet deadlines, multitask, and change priorities while maintaining productivity. 

• Ability to work well independently and in a team environment 
• Must be able to stand for extended periods and lift at least 25 pounds
• Must have own, reliable vehicle to drive to Milford, MA (Monday - Friday) to report to work (Milford does NOT have public transportation)

Salary : $25