Job ID: 2024-3928 Type: Regular Full-Time # of Openings: 1 Category: Quality Assurance Cambrex - High Point
Overview
Responsible for ensuring all laboratory instrumentation and associated software systems are in a state of regulatory compliance and readiness. Maintain system for tracking equipment on site, and coordinate with vendors or internal resources to perform maintenance, calibration, and repairs on all analytical laboratory equipment.
Responsibilities
Write instrument calibration, qualification, and validation documentation compliant with site SOPs and cGMP.
Schedule and execute on-time IQ/OQ, calibration, routine maintenance, and re-calibration activities of pharmaceutical laboratory equipment in compliance with applicable SOPs minimizing impact to laboratory activities and manufacturing. Proactively communicate timelines. Maintain strict timelines while demonstrating flexibility in day-to-day activities and scheduling. Update the calibration schedule and equipment lists as work is performed.
Provide advanced level expertise in responding to troubleshooting and repair requests to ensure uninterrupted operation of essential instrumentation. Demonstrate initiative in responding to situations as they arise and in accordance with all applicable SOPs.
Strong ability to effectively manage and organize multiple tasks & responsibilities with simultaneous competing priorities in a high-paced environment.
Set up standard and special purpose laboratory equipment to test, evaluate, and calibrate other instruments and test equipment.
Maintain inventory to ensure adequate parts and supplies are in stock.Complete requisitions for equipment and parts as needed.
Administer users and conduct standard configuration within instrument software.
Act as an escort for the approved vendors performing required external calibration and review calibration notebooks per applicable SOPs/procedures.
Manage laboratory equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
Promote and provide excellent customer service and support. Maintain a positive relationship with all the members of CHP while promoting a positive team environment.
Comply with Good Manufacturing Practices (GMP) and follow company policies and safety regulations.
Supervisory responsibilities for Analytical Instrumentation Specialist including performance management.
Responsible for training new or existing analytical instrumentation team members.
Qualifications
BA/BS in chemistry, life sciences, metrology, or related engineering or science discipline or equivalent (experience + education) plus minimum 9 years of experience in FDA-regulated pharmaceutical manufacturing industry, with minimum 5 years hands-on laboratory experience in equipment calibration/qualification.
Experience in Quality System/Pharmaceuticals, planning maintenance &/or calibration activities, and investigating OOT results is a plus.
Strong working knowledge of Agilent ChemStation/Open Lab, Waters Empower, and Nugenesis.
Strong knowledge of cGMP guidelines, FDA 21 CFR Part 11, 210/211, and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.
Strong knowledge and experience in the operation and qualification of pharmaceutical laboratory, facilities and manufacturing systems.
Demonstrated strong knowledge of metrology practices and theories and understanding of industrial instrumentation and measurement principals.
Good troubleshooting and problem-solving skills; ability to analyze and diagnose instrument failures rapidly and effectively.
Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential.
Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.
Ability to read/review design drawings with a basic understanding of P&ID, HVAC, & Electrical systems.
Understanding of technical documents such as URS, SAT, FAT, Validation Protocols.
