Quality Control Specialist I, Laboratory Instrumentation I

Duties & Responsibilities • Manages instrument qualification, maintenance, and calibration schedules, coordinating vendor onsite visits and maintaining scheduling and status within the company CMMS

• Coordinates and supports vendor activities during onsite maintenance, calibration, qualification, and repair services

• Provides technical support to maximize system availability, system uptime, and business continuity

• Manages laboratory equipment lifecycle activities including implementation, upgrades, integrations, and retirement activities

• Coordinates resources as needed to maintain equipment in an operational and qualified state.

• Maintains system lifecycle documentation to ensure laboratory equipment remains qualified, calibrated, and fit for intended use in accordance with data integrity, company policies and procedures, and applicable regulatory requirements

• Ensures appropriate user training is established for newly implemented systems to support equipment operation and maintenance

• Performs instrument qualifications/calibrations where appropriately trained

• Performs assigned responsibilities in accordance with cGMP and GDocP standards as defined in company procedures and regulatory requirements

• Performs other related duties and assumes additional responsibilities as needed to support business and organizational initiatives

Requires Skills & Abilities • Excellent verbal, written, and interpersonal communication skills with the ability to collaborate effectively with cross-functional teams and external vendors

• Strong organizational skills and attention to detail

• Strong time management skills with ability to manage priorities and meet deadlines in a dynamic environment

• Strong troubleshooting, analytical, and problem-solving skills

• Communicates effectively and maintains productive relationships with coworkers, vendors, and other contacts outside of the company

• Demonstrates ability to receive and provide constructive feedback

• Proficiency with Microsoft Office Suite and related applications

Education & Experience • Bachelor’s degree in a scientific discipline or related field, with 2 years of relevant experience preferred; or

• Master’s degree in a scientific discipline or related field, with 1 year of relevant experience preferred

• Requires 1 year GMP experience

Physical Requirements • Prolonged periods of sitting or standing at a desk and working on a computer.

• Must be able to lift up to 25 pounds at times.

• Adheres to consistent and predictable in-person attendance.