About the role
Serán is seeking a Quality Control Specialist with Instrumentation experience who will be responsible for managing laboratory equipment lifecycle and associated systems including planning, implementation, ongoing support, upgrades, maintenance, and system retirement. This person will develop and maintains equipment management processes/documentation, and manage projects to ensure systems remain in a qualified state and are fit for intended use.
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.