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Manufacturing Operations Specialist

1 month ago


Durham, North Carolina, United States KBI BioPharma Full time
Job Summary

This position is responsible for supporting the execution of production activities in a GMP environment. The ideal candidate will maintain a sense of ownership of the production processes and manufacturing environment, ensuring all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).

Key Responsibilities
  • Execute production activities in a GMP environment, following established procedures and protocols.
  • Ensure all work is conducted in accordance with GMP, GDP, and GLP principles.
  • Perform operations in a cleanroom environment, applying controls to ensure aseptic processing.
  • Document each task involving manufacturing procedures, following GDP guidelines.
  • Utilize and perform maintenance on equipment, per applicable SOP.
  • Ensure all items are issued and accounted for during the execution of a record.
  • Participate and be accountable for room 5S.
Requirements
  • High school diploma.
  • Ability to follow written instructions.
  • Excellent written and verbal communication skills.
  • Must be organized and able to focus in a fast-paced, multi-tasked environment.
  • Must have high attention to detail.
  • Ability to work a 12-hour schedule, including weekends, nights, and holidays.
Preferred Qualifications
  • Basic knowledge of cell culture or fermentation unit operations.
  • Experience in single-use platform technology.
  • Biowork certification.
  • Experience in CDMO.
Benefits

KBI Biopharma offers a comprehensive total rewards package, including an annual bonus structure, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days, and employee recognition programs.

KBI Biopharma is committed to providing a safe and healthy workplace. All employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination that has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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.