QA Specialist II (Nights 12 hour Rotating Shift)

KBI Biopharma • Durham, NC

10d • Onsite

About The Position

The Manufacturing Quality Assurance (MQA) Specialist is responsible for supporting the Manufacturing process and areas as part of a rapidly expanding GMP Contract Manufacturing Organization. MQA Specialists are expected to provide sound guidance to Manufacturing with respect to process, SISPQ of product, and risk. MQA Specialists share responsibility for the inspection readiness of the site. MQA Specialists are required to work on the cleanroom floor directly with the Manufacturing team to provide real time guidance and support. MQA Specialists are required to collaborate with Manufacturing and work on team initiatives. The MQA Specialist may also be responsible for coaching and mentoring as needed to foster a GMP compliant site. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to: Executed Batch record review and approval, Logbook review and approval, Deviation Triage Record guidance and generation, Routine facility walkthroughs, Facility response for work compromising clean environment, SOP review, Bulk Fill Label reconciliation, Alarm response and acknowledgement, Support external client review and resolution of comments.

Requirements

• Associate degree / Bachelor’s degree strongly preferred or appropriate years of experience (approximate 4-6 years).
• Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization.
• Demonstrated ability to represent Quality on interdepartmental meetings.
• Demonstrated knowledge of technical documents.
• Demonstrated ability to become qualified trainers.
• Ability to track and trend department metrics.
• Review written procedures for accuracy and provide feedback as needed.

Responsibilities

• Provide sound guidance to Manufacturing with respect to process, SISPQ of product, and risk.
• Share responsibility for the inspection readiness of the site.
• Work on the cleanroom floor directly with the Manufacturing team to provide real time guidance and support.
• Collaborate with Manufacturing and work on team initiatives.
• Coach and mentor as needed to foster a GMP compliant site.
• Execute core activities including: Executed Batch record review and approval, Logbook review and approval, Deviation Triage Record guidance and generation, Routine facility walkthroughs, Facility response for work compromising clean environment, SOP review, Bulk Fill Label reconciliation, Alarm response and acknowledgement, Support external client review and resolution of comments.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree