What are the responsibilities and job description for the Quality Assurance Specialist I position at Boston BioProducts?
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.
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 Quality Assurance Specialist III in the management of eQMS.
- Assist Quality Assurance Specialist III 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 Quality Assurance Specialist III in drafting and updates of QMS documentation as needed.
- Assist Quality Assurance Specialist III in maintaining the Quality Records and production documentation within eQMS.
- Assist in additional duties delegated from Quality Assurance Specialist III and Quality Lead.
Qualifications & Requirements
- Associate's degree in a scientific discipline or equivalent with 2-3 years experience
- Bachelor's degree in a scientific discipline or equivalent with 0-3 years experience
- 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
