AskBio Inc
Senior Calibration Technician
Durham, NC · Senior
Sponsorship not specifiedDetected 4 days ago
ComplianceRecruitingGMPFDA RegulatoryCRISPRResearchLeadershipCommunicationCollaborationMicrosoft OfficeGxP
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odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- This is an onsite position based in RTP, NC.
- The position will report to the Manager, Calibration and Instrumentation.
- Team Leadership: Train, and mentor calibration technicians (Levels I and II), ensuring consistent execution of calibration procedures and adherence to Good Manufacturing Practices (GMP)
Responsibilities
- Procedure Development: Develop, validate, and update calibration procedures and protocols, ensuring alignment with USP, ICH guidelines, and manufacturer specifications
- Troubleshooting and Maintenance: Diagnose and resolve complex issues with process and laboratory equipment, performing or overseeing repairs to maintain compliance and operational efficiency
- Documentation and Reporting: Maintain detailed calibration records, generate Certificates of Calibration, and ensure documentation meets regulatory requirements for audits and inspections
- Quality Assurance: Verify calibration results against standards, investigate out-of-tolerance conditions, and implement corrective actions to ensure product quality and compliance
- Calibration Program Management: Develop and manage calibration schedules, prioritize tasks, and coordinate with operations and quality teams to minimize downtime in manufacturing and laboratory environments
- Audit Support: Prepare for and support internal and external audits (e.g., FDA, EMA) by providing calibration records, procedures, and technical expertise
- Continuously drive improvements and efficiencies.
Requirements
- Ability to lift and handle equipment (up to 50 lbs, depending on the role)
Nice to have
- Primarily work in cleanrooms, laboratories, or GxP compliant facilities
- Adhere to strict safety and gowning protocols, including the use of personal protective equipment (PPE)
- Bachelor's degree in related field with 5+ years of related work experience
- OR Master's degree in related field with 3+ years of related work experience
- OR High School diploma with 9+ years of related work experience
- Expert knowledge of calibration principles and metrology in pharmaceutical/biotech applications
- Proficiency with calibration of equipment such as autoclaves, incubators, chromatography systems, and environmental monitoring systems
- Strong understanding of FDA regulations, GxP, and ISO 17025 requirements
Benefits
- Have a bias for learning and action.
Company info
- Lead innovative science and drive clinical outcomes to transform people's lives.
- Our principles:
- Advance innovative science by pushing boundaries.
- Bring transformative therapeutics to patients in need.
- Provide an environment for employees to reach their fullest potential.
- Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
- Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
- Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
- Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
- Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.
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