Supervisor, Manufacturing QA (Night Shift)

KBI Biopharma • Durham, NC

2d • Onsite

About The Position

The Manufacturing Quality Assurance (MQA) Supervisor is responsible for supervising the MQA team who supports the Manufacturing Process and Areas as part of a GMP Contract Manufacturing Organization. MQA Supervisors are expected to provide sound guidance to MQA team and Manufacturing with respect to process, SISPQ of product, and risk. The MQA Supervisor’s team shares responsibility for the inspection readiness of the site. MQA Supervisor routinely work on the cleanroom floor directly with the MQA and Manufacturing team to provide real time guidance and support. The Supervisor must adhere to procedures and policies to work on the Manufacturing floor. MQA Supervisor routinely collaborates with Manufacturing and work on team initiatives. The MQA Supervisor is responsible for coaching and mentoring their teams as needed to foster a GMP compliant site.

Requirements

• Bachelor’s Degree or higher degree and appropriate years of experience (at least 6 years) in a Quality or Technical role in a GMP setting required.
• 1-2 years of Supervisory experience preferred.
• Demonstrated ability to provide leadership to team.
• Strong understanding of technical and compliance regulations for Clinical and Commercial Biopharmaceutical Programs.
• Ability to read and comprehend instructions, correspondence, and memos.
• Ability to write routine correspondence.
• Ability to respond to common inquiries or complaints from employees and/or clients.
• Ability to manage and prioritize multiple efforts independently.
• Ability to write, follow, issue, and explain clear instructions furnished in written and oral form.
• Ability to use risk to make decisions.
• Ability to methodically solve problems to their root causes.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
• Ability to walk job sites, gown into cleanroom areas, lift small equipment and tools.
• Microsoft Office Programs, E-mail, Electronic Document Management Systems, Electronic Batch Record Systems.
• Computers

Nice To Haves

• 1-2 years of Supervisory experience preferred.

Responsibilities

• Supervise MQA team supporting Manufacturing.
• Provides training, coaching, and mentoring as needed.
• Works directly with MQA team/Manufacturing to resolve deviations and other compliance issues in a timely manner.
• Attend relevant operational meetings as MQA representative
• Perform Change Control assessments for MQA
• Performs client support relating to Batch Record reviews

Benefits

• KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees