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Perform and document laboratory equipment qualification (IQ, OQ, PQ) in compliance with GxP and GMP standards.
Schedule and conduct routine calibration, maintenance, and repairs for laboratory instruments and equipment.
Troubleshoot equipment issues and coordinate with vendors for advanced technical support as needed.
Compliance and Documentation:
Ensure laboratory operations and equipment are compliant with regulatory standards, including GxP, GMP, and other pharmaceutical guidelines.
Maintain accurate and up-to-date documentation for all equipment qualifications, maintenance, and operational activities.
Support audits and inspections by preparing required documentation and addressing compliance queries.
Process Improvement:
Identify and implement improvements to laboratory operations, workflows, and systems.
Assist in the integration of new laboratory technologies and methodologies to enhance efficiency and compliance.
Training and Support:
Train laboratory staff on equipment usage, qualification procedures, and operational best practices.
Provide technical support and guidance to ensure laboratory operations meet high standards of quality and compliance.
Regulatory Support:
Collaborate with quality assurance teams to align laboratory operations with regulatory requirements.
Participate in the development and review of Standard Operating Procedures (SOPs) related to laboratory activities.
Qualifications and Requirements
Educational Background
Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or a related field.
Experience
Proven experience in laboratory operations within the pharmaceutical manufacturing industry.
Hands-on experience with laboratory equipment qualification (IQ, OQ, PQ) and maintenance.
Strong understanding of GxP, GMP, and other pharmaceutical regulatory requirements.
Skills
Proficiency in laboratory instruments and systems, including troubleshooting and maintenance.
Excellent organizational and documentation skills, with strong attention to detail.
Ability to manage multiple priorities in a dynamic, fast-paced environment.
Strong interpersonal and communication skills to collaborate effectively with laboratory staff, vendors, and regulatory bodies.
HTC Global Services
Established in 1990, HTC Global Services is an Inc. 500 Hall of Fame company and one of the fastest growing Asian American companies in the US with headquarters in Troy, Michigan. A global provider of IT Solutions and Business Process Outsourcing services, HTC’s client base spans several Global 2000 organizations. HTC is committed to providing solutions that translate into tangible business outcomes for our customers. HTC manages IT environments, IT applications, and business processes of customers, focusing on providing transformational benefits.
Mission:
We are a global IT solutions provider adding value to our clients and people through emerging technologies. We are dedicated to the success of our clients, employees, business partners, suppliers, community, and stakeholders.
Job ID: 146941097
