Sr. Specialist, Compliance QA
$88,000–$108,000 year
On-siteRaleigh, North Carolina, United States
Job Summary
Author Annual Product Reviews, conduct site self-inspections, and manage Change Control and CAPA records to ensure regulatory compliance and inspection readiness. Develop and maintain systems for quality agreements, release components and raw materials, and perform QA review of incoming materials in the ERP System. Facilitate data compilation for audit reports, track open records in eQMS to closure, and coordinate vendor-initiated changes and complaints. Provide guidance on GDocPs application and review lab data as needed. Participate in multi-functional project teams and customer/regulatory audits. Requires Bachelor's degree, five years GMP/GXP experience, and proficiency with Veeva. Starting salary $88,000-$108,000 USD with comprehensive benefits.
Required Qualifications
- Bachelor's Degree in life sciences, engineering, or a related technical discipline from an accredited university
- Minimum five (5) years GMP/GXP Pharmaceutical experience
- In-depth knowledge of current GMP/GXP as well as FDA trends and guidelines
- Experience authoring Annual Product Reviews
- Experience conducting internal audits
- Excellent technical writing skills and technical reviewer experience
- Ability to communicate effectively both verbally and in writing with all levels of employees on all aspects of compliance
- In-depth knowledge of quality assurance terminology, methods, and compliance tools
- Computer skills
- Organized, detailed, and have ability to handle multiple tasks at once and redirect focus based on company's needs
- Adaptable to schedule changes, shifts in priority and cross-functional task alignment
- Proficient with problem-solving and risk mitigation
- Team focused, motivated and foster a positive and accepting environment
- Less than 10% travel
Desired Qualifications
- Certified Quality Auditor
- Experience with Veeva
- Experience reviewing lab data and audit trail data
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