Manufacturing Operations Specialist

5 days ago


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

This position is responsible for the execution of production activities in a GMP environment, focusing on media and buffer preparation. 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
  • Manufacture products per manufacturing batch records and in compliance with quality standards, company policies, and current regulations.
  • Perform operations in a cleanroom environment, applying controls to ensure aseptic processing, including gowning and cleaning procedures.
  • Document each task involving manufacturing procedures, following GDP at the time of execution.
  • Utilize and perform maintenance on equipment per applicable SOP.
  • Ensure all items are issued and accounted for during the execution of a record.
  • Demonstrate, apply, and ensure understanding of current Good Manufacturing Practices and how they apply to specific tasks and responsibilities.
  • 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 and maintain operational efficiency and positive demeanor.
  • Energetic, motivated, and dynamic individual.
  • Must have high attention to detail.
  • Ability to work a 12-hour schedule to include 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.
Compensation

$ /hour plus a night shift differential. Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range.

KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days, and employee recognition programs.

KBI Biopharma, Inc. is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.

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.



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