The Opportunity:
As a Quality Assurance (QA) Batch Record Release Coordinator, you will be responsible for auditing paperwork for accuracy based on required documentation release, quarantine, or reject product, as needed. Additionally, you will monitor data using computer-based tracking programs on a routine basis.
You will have the opportunity to build strong relationships within our Quality Assurance Teams and interact with colleagues throughout the organization.

QUALIFICATIONS

• Diploma/high vocational certificate or university degree
• Quality Assurance experience in a manufacturing environment including significant auditing experience preferred
• Strong IT skills, including proficiency with Excel, Word, PowerPoint, and basic business tools Functional knowledge and experience in all areas of quality and/or compliance based on practical experience, including Food & Drug Administration (FDA) regulations and Current Good Manufacturing Practice (CGMP) requirements
• Solid understanding of chemical nomenclature and general manufacturing concepts and terminology
• Experience with SAP highly preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Ability to work collaboratively in a team and create an inclusive environment with people at all levels of the organization
• Ability to communicate complex ideas effectively, both verbally and in writing, in English and the local office language(s)
• Ability to effectively manage shifting deadlines and priorities; solid analytical skills
• Confident, professional demeanor; can-do attitude and desire to deliver great service
• Strong problem-solving skills with ability to process complex information, break it into logical steps/tasks to help solve the problem

• Match and verify Batch Production Records (BPRs) and bench sheets for manufacturing related goods and perform audit of job packets and label reconciliation in accordance to ALCOA+
• Release material on Information Management System (IMS)
• Maintain BPRs audit log including tracking audit results statistics
• Filing and storage of quality records
• Support in the monthly stability / retention samples traceability and completed results in system
• Maintain quality status of inventory and support with Material Review Board (MRB) process of related goods
• Assist in Quality system maintenance such as the creation and maintenance of quality documentation
• Input, track local and tiered level quality objectives into relevant system for data analysis
• Collaborate with team members to support company and assigned goals
• Support in all internal, external and customer audits for documentation readiness
• Support and participate in any quality event / complaint / change control and other quality modules for compliance
• Perform verification work such as access control and audit trail of laboratory equipment
• Support in any validation related documentation to ensure accurate, completeness and compliance.
• Any other ad-hoc task / project assigned.