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.