QA Specialist II - Operations

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. A Quality Assurance Specialist Operations II plays a pivotal role in the launch and ongoing operations of the Quality Assurance organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC.

Requirements

• Bachelor's degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology, or related field) preferred, with a minimum of 2 years relevant experience in biopharmaceutical manufacturing also preferred.
• At least 2 years of experience in a GxP regulated environment, with a focus on batch record review, batch disposition, Shop Floor QA, Manufacturing Quality Assurance, and/or Incoming Quality Assurance.
• Experience with start-up and operation of biopharmaceutical manufacturing processes is a plus.

Benefits

• 401K with company matching
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards