Sr. Specialist, Quality Assurance

About the position

Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective. The role requires knowledge of quality systems and approaches, understanding of relevant regulations, standards, and operating procedures, and the ability to perform investigations and root cause analysis. The position also involves performing gap assessments, understanding quality concepts, and working cross-functionally to interpret and educate others on quality requirements.

Responsibilities

• Maintains accurate and current Quality records
• Performs real-time QA review of batch documentation and other GMP related documents
• Issuance and reconciliation of product labels for production
• Perform AQL testing for visual inspection
• Understands technical/release product issues and evaluates their potential impact on product quality and compliance
• Champions Quality, GMP compliance and EHS/Radiation Safety practices
• Networks across business and functional units to achieve positive outcomes
• Assists Quality Management with FDA and other regulatory agency activities
• Demonstrates efforts to discover, meet and advocate for the customer's needs
• Takes actions to continually improve quality and safety in daily work
• Reports errors in a timely and appropriate manner
• Demonstrates ability to act calmly and patiently when working under pressure
• Performs other job duties as assigned

Requirements

• Bachelor's in science related field (processing engineering, Chemistry, Biology) or equivalent work experience preferred
• 2+ years' experience in related field preferred
• 2 years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred
• Possess an understanding of cGMP/compliance requirements for cosmetic and pharmaceutical products
• Working knowledge of Microsoft Office Suite specifically Microsoft Word and Excel strongly preferred
• Working knowledge of Adobe editing software strongly preferred
• Working knowledge of Document Management software (Trackwise and/or Smartsolve) strongly preferred
• Demonstrated ability to manage timelines and priorities
• Demonstrated to work independently with minimum guidance
• Demonstrated to multi-task and focus attention to detail

Nice-to-haves

• Experience in a radiopharmaceutical manufacturing facility
• Familiarity with quality metrics and statistics

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs