Supervisor, Manufacturing Support

Supervisor, Manufacturing Support

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Night shift, hours are 7 PM – 7 AM, working a 2-2-3 schedule.

A Supervisor in the Manufacturing Support Department will coordinate and supervise Manufacturing Support operations such as cleaning of GMP facilities, PAR operations, raw material sampling, and process waste operations. The Supervisor will ensure compliance with all regulatory guidelines, company policies, SOPs, and PDs. The role involves troubleshooting operational issues, facilitating support with external departments when necessary, guiding, mentoring, and coaching personnel, and maintaining ownership of all support department operations during the shift.

The Supervisor will use the Quality System (CAPA, Deviation, Change Control, and Training) to ensure compliance, and will lead by example while modeling KBI values. The duty is to ensure safety and compliance of each person on KBI property.

• Support and train supervised associates to complete daily tasks.
• Ensure learning and development of departmental associates.
• Responsible for ensuring manufacturing compliance with GDPs and cGMPs with logbook and record entries.
• Facilitate responsibilities required to support operations.
• Communicate with external departments to schedule and complete required tasks.
• Initiate Compliance Quality Systems such as deviations, CAPAs, and change controls related to the support department.
• Perform support for annual/biannual performance reviews of direct/indirect reports within the department.
• Adhere to all safety requirements and report unsafe conditions.
• Ability to work outside routine schedules to maintain support operations when necessary.
• Write/revise department SOPs, TRNs, and manufacturing records.
• Perform change control assessments related to support department functions.
  
  Require strategic planning and decision making to ensure continuous operations while remaining compliant with policies and procedures.
• Review and approve direct reports’ timesheets and PTO requests.

• High school diploma with 8+ years of relevant manufacturing experience; or associate degree with 6 years; or bachelor’s degree with 4 years of relevant manufacturing experience.
• 2+ years of prior leadership/supervisory experience.
• Knowledge of quality assurance systems and regulatory agency guidelines preferred.
• Excellent written and verbal communication skills.

• Hours may vary depending on business needs and unforeseen circumstances.
• Use of Spor-Klenz requires respirators (full face and half face). Facial hair must be kept short to maintain seal.
• This position is considered “Essential Personnel” requiring 7 days a week coverage even when the company is closed to ensure cleaning is completed daily.

Salary Range: $101,000 – $138,600 per year, based on experience. Salary and job title may be outside this range. KBI offers an annual bonus structure, medical, dental, vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days, and employee recognition programs.

KBI Biopharma, Inc. is an EEO/AA employer that actively seeks to diversify its workforce. 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 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 employment at any time and for any reason, with or without cause and without notice. I understand no representative of KBI Biopharma, Inc.

has authority to make any assurance to the contrary. I attest that I have given true and complete information on this application, that no requested information has been concealed, and that I authorize KBI Biopharma, Inc. to contact references for employment checks. Untruthful information or concealment constitutes cause for denial of employment or immediate dismissal.

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