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Calibration Document Assistant I

2 months ago

Carlsbad, United States BioPhase Full time

Calibration Document Assistant I


Location: San Diego, CA / Research & Development

Pay: $20-23 per hour

Duration: Until the end of the year (with potential for temp-to-hire)

Shift: First


Position Summary:

In this onsite role, you will be a crucial part of the calibration documentation program, ensuring compliance with regulatory standards. You will work closely with the Engineering, Metrology, and Manufacturing Maintenance departments and report to the Manager of Manufacturing Engineering. Your responsibilities will include supporting the calibration documentation system for scheduled calibrations and preventative maintenance. The results of your work may be reviewed during audits. Familiarity with FDA-regulated environments and a commitment to maintaining data accuracy for ISO 9001 compliance is essential.


Essential Functions:

  • Update and maintain accurate and detailed calibration records and maintenance documentation using the Enterprise Asset Management (EAM) preventative maintenance system.
  • Communicate project status updates and information requests both verbally and in writing.
  • Perform duties in compliance with established business policies.

Interactions:

  • Work closely with Manufacturing, Manufacturing Maintenance, Engineering, and Quality Systems teams.

Work Environment:

  • The work environment is a combination of office and laboratory settings, with some time spent in production and warehouse areas. Flexible work hours may be required to meet product demand deadlines.

Physical Demands:

  • The position may require occasional lifting of up to 20 lbs.
  • Approximately 80% of the time will be spent seated at a desk doing computer work, paperwork, or phone communication, with the remaining time spent in meetings or walking in manufacturing areas.
  • The role may require the use of Personal Protective Equipment (PPE) as needed.


Requirements:

Education/Experience:

  • AA/AS in Life Sciences, Laboratory, Manufacturing, or a related field, or 3 to 5 years of relevant experience.
  • Experience in an FDA-regulated environment is strongly preferred.

Knowledge/Skills:

  • Proficiency in Microsoft Office, particularly Excel.
  • Strong attention to detail with excellent documentation skills.
  • Ability to follow routine procedures independently and work effectively as part of a team.
  • Excellent time management skills to achieve goals in a timely manner.
  • Knowledge of cGMP manufacturing and an understanding of ISO 9001.
  • Reliable attendance and the ability to work collaboratively in a team environment.