KBI: US - QA Specialist II

Job Summary 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 the clean environment SOP review Bulk fill label reconciliation Alarm response and acknowledgement Support external client review and resolution of comments Key Responsibilities Provide real‑time support of the Manufacturing process on the floor, including compliance review of records and aid in deviation determination/generation. Collaborate directly with manufacturing, laboratory, and other GMP‑related departments to resolve deviations and other compliance issues promptly. Support process improvement projects to enhance on‑floor Quality activities, reduce record review time, and expedite batch release dates. Conduct facility walkthroughs, tracking and trending recurring observations. Assist in resolving client comments to support batch release activities. React productively to change and handle other essential tasks as assigned. Represent Quality at interdepartmental meetings. Qualifications MQA Specialist I High school diploma or equivalent; degree progression preferred. GMP / regulated industry / laboratory experience required (approximately 1‑3 years). Demonstrated ability to work in a team environment. Demonstrated ability to understand the manufacturing process. Ability to perform routine core MQA responsibilities. Review written procedures for accuracy and provide feedback as needed. MQA Specialist II Associate degree / Bachelor’s degree strongly preferred or equivalent experience (approximately 4‑6 years). Demonstrated ability to work in a team environment and strong communication skills at all organization levels. Demonstrated ability to represent Quality at interdepartmental meetings. Demonstrated knowledge of technical documents. Demonstrated ability to become a qualified trainer. Ability to track and trend department metrics. Review written procedures for accuracy and provide feedback as needed. Compensation & Shift Salary: $55,000‑$86,900. MQA Specialist shifts are 12 hours in duration (0700‑1900 or 1900‑0700) and operate on a 2‑2‑3 schedule to provide 24/7 site coverage. EEO Statement KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. #J-18808-Ljbffr KBI Biopharma