Almac Group is currently seeking a Calibration Coordinator for our Souderton, PA location. The Calibration Coordinator will be responsible for the scheduling, coordination, execution, and documentation of the calibration activities ensuring GxP regulatory compliance is maintained on behalf of the Almac Business Units.
Responsibilities include but are not limited to:
- Coordinate daily calibration activities within a GxP regulatory environment to maintain a high level of support to each Almac Business Unit. Through collaboration with area process owners, schedule instrumentation calibrations into operations with the objective of minimizing downtime while ensuring calibrations are completed and documented in compliance with relevant SOPs and to GxP standards.
- Execute the calibration operation phase activities including planned and unplanned calibration work orders carried out internally or by contracted service providers ensuring the work orders are completed and approved by the due date. Review and approve calibration certificates ensuring certificates are accurately aligned with the work orders and calibration labels have been applied. Provide immediate notification to the process owner for out of tolerance findings.
- Assist with the calibration project phase of instrument integration including critical risk assessment processes, instrument identification, instrument tagging, and supporting documentation. Assist with information collection that can be leveraged into the Master Calibration List.
- Provide calibration contracted service provider with the technical guidance required to accurately integrate instrumentation through the project phase and the operation phase of the calibration management process. Ensure the contractor is trained and complies with all SOPs and GxP standards required by each Almac Business Unit.
- Ensure that all calibration schedules are upheld and that all calibrations are completed prior to their due date.
- Ensure calibration labels are applied to instrumentation and are accurately aligned with the calibration certification and work order.
- Provide immediate notification for out of tolerance or other instrument deviations to the process owner.
- Coordinate the HEPA filter testing and other associated certifications into the Almac operational schedule ensuring the work orders and certification are completed and approved prior to the due date.
- Provide the required support of commissioning and decommissioning activities as defined with the calibration management process.
- Coordinate the company approved calibration contractors into the Almac Business Unit’s operational schedule while minimizing downtime.
- Ensure that all contractors and vendors are properly escorted, trained and remain compliant while performing calibration activities.
- Maintain a compliant status of the positions training curricula.
- Achieve a thorough understanding of all relevant policies and SOPs within the Company, ensuring that approved contractors adhere to all relevant SOPs and properly complete associated documentation and training records.
- Conform to safety guidelines and regulations to guarantee safe work practices of Almac staff and clients.
- Provide updates on critical issues to your line manager.
- Maintain good working relationships within Almac and its business units.
- Provide calibration support during scheduled equipment shutdowns or other activities required during non-business hours.
- Implementation of accurate, effective, and resourceful calibration support to the business units.
- Support calibration documentation requests during customer and regulatory audits performed on site.
Qualifications:
Required Experience / Education:
- High School Diploma or equivalent required
- Technical training through a certified technical institution in electronics or instrumentation
- 3+ years Calibration within a GxP/ISO environment.
- 1+ year GxP Documentation
- A thorough understanding of the technical details related to environmental instrumentation, test points, tolerances, and accuracy
- Calibration practices
- Building monitoring systems
- GxP practices
- Intermediate/advanced knowledge of calibration theories and principles
- Practical multi-meter use
- Intermediate understanding of electricity (AC/DC theory)
- Intermediate Microsoft Products
Preferred Experience / Education:
- Associates Degree or certification in a Specialized Technology field
- Pharma/BioTech/Life Sciences work experience
- Electronic theory
- AC/DC concepts
- Windows 7.0 / 10.0 operating systems
- Calibration Practices
What Almac Group can offer YOU!
- Full medical, vision & dental benefits the 1st of the month after start date
- 20 days of PTO to start plus 12 holidays per year
- Company paid long and short term disability along with life insurance
- 401k company match
- Professional development programs/ continuous learning opportunities
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing almost 5,600 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer – Minorities/Women/Protected Veterans/Disabled – Proudly embracing diversity in all of its expressions.
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Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [email protected] to request assistance.
Source: Indeed.com
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