QA Engineer

Description

• Create or modify SOPs and work instructions and recommend changes to batching instructions.
• Monitor and interpret the Federal Register and other sources for laws related to Food, Drugs, and Cosmetic Industries.
• Maintain quality attributes in customer specification portals.
• Assist in GMP and GDP training of new personnel.
• Define and improve systems and processes.
• Generate Annual Product Reviews (APR).
• Investigate root causes, write and implement CAPAs, and interact with necessary departments to ensure quality investigations and thorough CAPAs.
• Conduct customer complaint investigations.
• Maintain the quality system of Process Variance Reports (PVR).
• Ensure GMP required documentation complies with governmental regulations such as FDA.
• Evaluate data from current processes to recommend improvements, cost-effectiveness, and production quality.
• Perform Statistical Process Analysis to evaluate process control.
• Develop or assist with process control procedures and automation specifications to ensure ongoing compliance.
• Use Failure Mode and Effect Analysis (FMEA) and Hazard Operability (HAZOP) Studies to assess systems and processes.

Requirements

• 2-5 years’ experience in manufacturing of food, cosmetics, or pharmaceutical products.
• Auditing experience in manufacturing areas or involvement in quality investigations is a plus.
• Experience managing CAPAs in a lab, QC, or manufacturing environment.
• Proficiency in Microsoft Office products.
• Ability to coordinate with multiple departments to drive open CAPAs to completion.
• Experience with Quality Systems such as CAPA, deviations, auditing.
• Knowledge of FDA regulations and GMPs.
• Experience in quality assurance, particularly in managing open CAPAs post-audit or investigation.
• Bachelor’s Degree in a related Science or Engineering field.
• Broad QA experience in Quality Systems and project management.

Benefits

• Employee Assistance Program
• Critical Illness, Accident, and Hospital
• Health Spending Account (HSA)
• Short and long-term disability
• Transportation benefits
• Medical, dental & vision
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Time Off/Leave (PTO, Vacation or Sick Leave)
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Training + Development

Interview process

Visa Sponsorship

Security clearance