QC Equipment Sr Specialist

This position acts as liaison between Quality Control (QC) analysts performing testing, facilities personnel maintaining laboratory instrumentation and equipment, IT, and QA, and the supporting software systems that track equipment implementation, maintenance, and usage.
This position is dedicated to one QC site but may provide backup to other QC sites.
Principal Responsibilities
Work with QC, Facilities, IT, and QA to ensure equipment and associated software is managed in accordance with governing procedures.
Create new and review completed equipment records and tasks in the CMMS (computerized maintenance management system) as the System Owner.
Take lead role for equipment changes.
Write and revise equipment and software related documents (user requirements specifications, qualification/validation protocols, etc.).
Review executed equipment testing protocols and address exceptions that occur during testing execution by vendor or Facilities.
Address equipment alarms such as for temperature excursions including moving material to alternate storage unit, performing investigations into the cause for the excursion and assessing impact of the temperature excursion.
Arrange purchase and receipt of new equipment.
Perform data integrity and impact assessments for equipment and associated software.
Perform periodic reviews of equipment and associated software as the System Owner.
Perform equipment logbook reviews.
Coordinate with Facilities for scheduling calibration, maintenance, and repairs.
Work with QC Systems colleagues, Facilities, IT, QA, and customers to create and implement process improvements.
Support other equipment System Owners as needed.
A few hours of evening, weekend, and/or on-call work may be ocasionally required to address equipment alarms.
May administer training system for a QC site including but not limited to user access, organizing training assignments, providing customer support for questions.
Apply the principles of good manufacturing practices (GMP) on a daily basis.
Create and revise standard operating procedures (SOPs) and other documents as needed.
Identify and lead continuous improvement projects.
Maintain training to current standards and procedures on all assigned curriculums.
Fully comply with company health and safety procedures and practices.
Author and own deviations and CAPAs.
Train and mentor other personnel.
Represent QC in cross-functional project teams.
Participate as subject matter expert (SME) in regulating agency inspections, internal audits, and partner audits.
Required Qualifications
10+ years relevant experience
Bachelors degree or associates degree and 2+ years in relevant field
Ability to quickly adjust and re-prioritize current tasks based on strategy or timeline changes from sources within QC Systems, within QC, or outside of QC with little lead time or notice
Excellent customer service skills
Excellent communication and collaboration skills
Experience with Blue Mountain, Maximo, or other equipment maintenance management system
Experience using or managing analytical lab equipment (pH meters, balances, HPLCs, etc.)
Preferred Qualifications
Familiarity with general function of QC equipment (spectrophotometers, HPLCs, particle counters, CEs, plate readers, plate washers, freezers, refrigerators, incubators, pH meters, fume hoods, BSCs, etc.)