Quality Assurance Specialist

3 days ago

Milford, Massachusetts, United States Boston BioProducts Full time
Job Summary

Boston BioProducts is seeking a Quality Assurance Specialist I to ensure the quality of our products and services. The successful candidate will be responsible for ensuring that our products meet or exceed customer and regulatory expectations.

Key Responsibilities
  • Ensure that products manufactured meet or exceed customer and regulatory expectations.
  • Work with the Quality team and management to maintain a quality management system that complies with current standards.
  • Maintain vendor files with applicable documents.
  • Review batch records and other relevant documents.
  • Release and reject 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 Certificate of Analysis (CoA)s and Safety Data Sheet (SDS) from vendors.
  • Communicate with vendors as needed to obtain necessary documentation for incoming materials.
  • Generate CoAs, BSE/TSE statements, and other documents for BBP final products as needed.
  • Provide quality documents to customers upon request.
  • Assist Quality Assurance Specialist III in managing eQMS.
  • Assist Quality Assurance Specialist III in maintaining Quality Records and production documentation within eQMS.
  • Assist in records control of QMS and production documentation.
  • Assist in qualifying and approving prospective vendors.
  • Assist Quality Assurance Specialist III in drafting and updating QMS documentation as needed.
  • Assist Quality Assurance Specialist III in maintaining Quality Records and production documentation within eQMS.
  • Assist in additional duties delegated from Quality Assurance Specialist III and Quality Lead.
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.
  • Strong written and verbal communication skills, detail-oriented work ethic, and 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.

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