Contract Position until 12/24
Position Summary:
In this on-site role, you will play a key role in managing the calibration documentation program and ensuring compliance with regulatory standards. You will collaborate closely with the Engineering Metrology and Manufacturing Maintenance teams, reporting directly to the Manager of Manufacturing Engineering. Your primary responsibilities will include supporting the calibration documentation system for scheduled calibrations and preventive maintenance. The results of your work may be reviewed during audits. Experience in an FDA-regulated environment is essential, and maintaining data accuracy for ISO 9001 compliance will be a critical focus.
Key Responsibilities:
- Maintain and update precise calibration and maintenance records using the EAM (Enterprise Asset Management) preventative maintenance system.
- Provide regular project status updates and respond to information requests both verbally and in writing.
- Perform tasks in line with established business policies and regulatory guidelines.
- Work closely with teams from Manufacturing, Manufacturing Maintenance, Engineering, and Quality Systems.
Physical Demands:
- Must be able to lift up to 20 lbs occasionally.
- Approximately 80% of the workday is spent seated at a desk, performing tasks such as paperwork, computer work, or phone calls, with around 10% of time spent in meetings.
- Some walking in manufacturing areas is required.
- May require the use of Personal Protective Equipment (PPE) in specific environments.
Qualifications:
- Education/Experience: AA/AS degree in Life Sciences, Laboratory, Manufacturing, or a related field, or 3-5 years of relevant experience. Prior experience in an FDA-regulated environment is strongly preferred.
- Proficient in Microsoft Office, especially Excel.
- Strong attention to detail and excellent documentation skills.
- Capable of independently following routine procedures as well as working within a team.
- Effective time management skills to meet deadlines.
- Familiarity with cGMP manufacturing and a solid understanding of ISO 9001.
- Must be reliable, with the ability to maintain regular attendance and work collaboratively in team settings.