Quality Assurance Engineer II

Quality Assurance Specialist

Degree in Engineering, Biology, Chemistry, Science, or related degree required

Minimum of 2-4 years related experience

Proven ability to follow policies and procedures, instructions, and to meet schedules consistently and independently.

Experience in quality systems in distribution-related fields is a plus.

Strong understanding of SAP and E1 transactions (Quality and Inventory focused).

Knowledge of the FDA 820 and ISO13485.

Ability to multitask and achieve deadlines in a fast-paced environment

Strong communication skills, both verbal and written, organizational skills, both analytical and problem solving, and the ability to work with confidential documents

Duties and responsibilities:

• Work with quality team to ensure company goals and objectives, policies and procedures follow Quality Systems, cGDP, GDP, and FDA regulations
• Work directly with investigation teams on quality issues and TrackWise problem record closures.
• Support activities within the Quality Management System as required. Ensure quality systems SOPs are being followed and alert Quality team if any discrepancies found to drive escalation and corrective actions as needed.
• Support new and transfer product to be aligned with distribution requirements
• Write and revise Standards Operating Procedure for Distribution activities and develop training content.
• Perform daily Good Distribution Practices checks and enforcement.
• Perform inspection on Order fulfillment activities as required and ensure all packaging guidelines as well as good practices for Cold Chain pack-out are met.
• Demonstrate ability to work with the following systems is required: Microsoft Excel/Word, SAP, E1, Agile, and TrackWise
• Demonstrate ability to work effectively on multiple assignments concurrently and meet standard response times and deadlines.
• Demonstrate ability to reprioritize work quickly to meet changing demands.
• Possess good organizational skills and demonstrate strong ability to work well within a team setting as well as independently.