Provide quality assurance support throughout the production process for manufactured products.

• Coordinate Supplier/Provider Quality Program
• Maintain Approved Vendor List (AVL)
• Produce and maintain non-raw material specification and inspection forms
• Produce and maintain comprehensive raw material control records (RMCR) as required for in-coming inspection and approval of raw materials
• Maintain ERP raw material inventory status updates and issue raw material QA status labels
• Monitor and maintain the raw material retest program
• Produce and maintain cleaning forms as required for approval of production equipment
• Operate within the company’s standard operating procedures and review, maintain and create appropriate procedures for area of responsibility to ensure compliance with ISO 9001, cGMP, customer and Ortec requirements
• Abide by company and OSHA safety standards set for work area
• Review documents and forms according to good documentation practices (GDP), e.g. SOP’s, etc. for accuracy, clarity and completeness; generate/revise documents as needed following change control process
• Support product release through preparation and review of production documentation for accuracy, data integrity, traceability and GDP (raw materials, intermediates and final goods), review of COA/COC and material labels
• Prepare product documentation for customer review and approval when required
• Provide technical assistance to carry out problem analysis/complaint investigation where necessary, e.g. quality events investigation and CAPAs
• Maintain nonconforming/disposal records
• Assist with internal auditing, tracking and trending department metrics, KPI and quality indicators

• Microsoft Office (Word, Excel, PowerPoint, Outlook) proficiency required
• Demonstrate excellent interpersonal and communication skills and work as effective team member
• Attention to details, ability to meet deadlines and work independently in fast-paced environment
• ASQ Certification preferred