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 clean environment

• SOP review

• Bulk Fill Label reconciliation

• Alarm response and acknowledgement

• Support external client review and resolution of comments

JOB RESPONSIBILITIES

• On the floor real time support of the Manufacturing process. This includes 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.

Knowledge, Skills, Abilities

MQA Specialist I

− High School diploma or equivalent. Degree progression preferred.

− GMP / regulated industry / laboratory experience is required (approximate 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 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

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.

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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.