KBI: US - QA Specialist II

KBI Biopharma • Durham, NC

2d • 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

• On the floor real time support of the Manufacturing process.
• Performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks).
• Aid in deviation determination/generation, general Quality guidance.
• Works directly with manufacturing, the laboratory, and other departments responsible for GMP activities to support resolution of deviations and other compliance issues in a timely manner.
• Support process improvement projects to include improving on the floor Quality activities, record review time, and batch release dates.
• Performed Facility Walkthroughs including tracking and trending reoccurring observations.
• Works directly with manufacturing, and other internal departments to support resolution of client comments in a timely manner in support of batch release activities.
• Able to react to change productively and handle other essential tasks assigned.
• Quality representation on interdepartmental meetings.

What This Job Offers

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