Specialist, Quality Assurance

About the role

The QA Operations Specialist is responsible for providing quality oversight of the day-to-day manufacturing operations for Drug Substance Manufacturing. This is primarily achieved through record and data review, area inspection, and incident resolution.

Responsibilities

• Reviews executed batch and formulation records, ensuring production activities were performed as required and documentation meets requirements.
• Reviews electronic audit trails for manufacturing instruments and equipment, identifying orphan data and other anomalies.
• Provides compliance oversight of the manufacturing facility, including area inspections and changeover confirmations.
• Acts as quality resource for manufacturing personnel, especially pertaining to documentation and area readiness.
• Documents findings in the quality system and supports resolution.
• Manages assigned workflows to ensure all required timelines are met and escalates if work is off-track.
• Performs other duties as assigned.

Requirements

• High School Diploma or Equivalent with 9 years of applicable industry experience OR Associates degree with 7 years of applicable industry experience OR Bachelor's degree with 5 years of applicable industry experience OR Master's degree with 3 years of applicable industry experience
• Strong verbal and written communication skills to partner with different teams and stakeholders
• Strong time management skills: ability to meet tight deadlines and ensure effective prioritization of tasks
• Excellent oral and written communications skills and fluency in English
• Fundamental knowledge and application of cGMP compliance and other related regulations
• Awareness of GAMP5, ALCOA++, Data Integrity, and application of 21 CFR Part 820 and Part 11
• Understanding of cell culture, fermentation, recovery and/or downstream processes
• Team based attitude and ability to build relationships, and communicate effectively with others
• Embraces a Genki culture, able to bring positive energy to a dynamic work environment
• Must be flexible to support 24/7 manufacturing facility

Preferred

• Experience with Trackwise, SAP, Kneat and/or Veeva

Benefits

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays.