Job Description
Job DescriptionSalary: $25-30 DOE
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 an entry-level position in the Quality Assurance team. Please note that while it is part of the Quality department, it is not a regulatory 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)