Quality Assurance Specialist

Responsibilities

• Ensure products manufactured by BBP meets or exceeds customer expectations and quality standards
• Works in conjunction with the Quality team and management to maintain a Quality Management System that complies with current regulatory and industry requirements
• Review batch records and other relevant documents to ensure accuracy, completeness, and compliance with GDP and established procedures.
• Create the CoA and ensure all product specifications are accurate
• Identify and report any discrepancies observed during batch record reviews to the Quality Operations Manager
• Ensure that the product meets the specification and client criteria prior to release
• Ensure the releasing and rejecting of materials, intermediates, packaging, and labeling materials, as applicable
• Review In process forms, protocols, and records for adherence to Good Documentation Practices (GDP)
• Ensure that Certificate of Analysis (CoA), Safety Data Sheet (SDS), and BSE/TSE statements are obtained from vendors. Communicate with vendors as needed to obtain the necessary documentation for incoming materials
• Coverage of Change Orders and Deviations related to products per customer request
• Coverage of coordinating with other departments to ensure releasing raw materials and finished goods within the timeline
• Aid in drafting, processing, investigation, and reporting of Deviations, NCRs, CAPAs and customer complaints
• Aid in investigating and identifying the root cause using appropriate analytical techniques for NCR investigations
• Perform QA periodic checks of all the functional area
• Ensure that CoA, BSE/TSE statements, and other documents generated within BBP are correct and delivered in a timely manner
• Maintain Quality Records and production documentation within eQMS
• Draft, review, and update QMS documentation as needed
• Support internal and external audits by preparing documentation, participating in audit activities, and assisting with follow-up actions
• Aid in responding to customer inquiries related to quality systems, compliance, and product documentation

Requirements

• Requires a Bachelor’s degree in a scientific discipline or equivalent
• Minimum 3-5 years of relevant experience
• Strong knowledge of ISO 13485, ISO 9001 and GMP
• 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 work independently, adhere to quality, production, and customer expectations and timelines
• Computer literate and experienced with Microsoft Office
• Skills in developing and organizing systems for the management of information
• Strong knowledge of chemistry preferred
• Ability to meet deadlines, multitask, and change priorities while maintaining productivity
• Well-developed attention to detail and the ability to maintain accurate records