Job Description

Job Summary

The Quality Assurance Engineer is responsible for supporting the Quality Assurance department for the operations of a pharmaceutical manufacturing facility.  The individual must have the ability to write reports clearly, concisely and accurately.  The individual must have strong knowledge and application of the CFR’s, Events, Change Controls, Batch Reports, and cGMP’s.

Responsibilities

• Assist with the integration and support of quality regulations: drug, biologics, device and/or combination products.
• Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
• Evaluate, analyze and trend quality indicators, data and performance metrics; communication and elevation of affiliate compliance status and risk while maintaining a continuous improvement objective.
• Partner, coordinate and support activities related to quality events (quality defects, security events, recalls etc) in the affiliate.
• Assist project teams in planning, preparation, review and approval of quality documentation.
• Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
• Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
• Establish training requirements related to Quality Systems and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.
• Coordinate and investigate quality events such as deviations, non-conformances, product complaints and corresponding action plans including decisions.
• To deal with Regulatory bodies as required through using complaint reporting processes.
• Execute quality plans and provide assistance to the various multi-disciplinary departments and teams with respect to planning and execution.
• Ensure metrics and KPIs are being met.
• Coordinate change control process to ensure changes do not introduce adverse impact to operation.

Requirements

• Minimum 4-year degree in a Science or Engineering field of study; or equivalent experience.
• Minimum 2 years QA/QC experience in pharmaceutical or other highly regulated industry.
• Experience in deviations and events, batch record reviews, protocol reviews, and procedural updates. 
• Working knowledge of cGMP practices including Good Documentation Practices.  Working knowledge of FDA, USP, ISO, and ISPE trends and guidelines.

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