Supervisor, Manufacturing QA (Night Shift) Job at KBI BioPharma in Durham

Job summary

12 hour night shift position to oversee the Manufacturing QA (Shop Floor QA) function at the KBI Biopharma Commercial Manufacturing Facility (CMF), supporting the manufacture of biopharmaceuticals, providing QA support on the manufacturing floor. Lead the QA on-the-floor inspection program, review of master and executed electronic batch records and log books and room changeovers/room releases. Provide support to resolve issues related to GMP manufacturing as needed. Level load work across team in support of batch release timelines, daily manufacturing schedules, and site project priorities. Provide coaching and mentoring to staff.

Job Responsibilities

• Supervise the Manufacturing QA group supporting GMP, commercial manufacturing of bulk drug substance (biologics)
• Manage QA oversight of ongoing GMP manufacturing activities. Performs QA on-the-floor inspections. Provides compliance support to manufacturing operators during processing on the floor.
• Performs QA review of master and executed batch records and logbooks in an electronic system
• Provide support to resolve issues related to GMP manufacturing as needed
• Works directly with Manufacturing Operations to resolve deviations and other compliance issues in a timely manner
• Support deviations, CAPAs, and change controls for manufacturing operations.
• Supervises direct reports providing coaching and mentoring
• Attend relevant operational meetings in support of disposition activities. Support client audits and regulatory inspections as required

Minimum Requirements

Preferred Knowledge, Skills, Abilities

• Bachelor's degree and 6+ years' experience or Master's degree and 4+ years' experience in a QA engineering, Quality on the floor, or technical services/manufacturing sciences role or equivalent in a GMP environment. 0 - 2 years of supervisory experience preferred. Proficient in project management and Quality Systems. Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills. Strong understanding of FDA, EU and ROW cGMP regulations is required. Experience in a commercial manufacturing environment is beneficial.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.