As a Senior QC Lab Instrumentation Analyst, you would support the Quality Control (QC) and Process Sciences (PS) departments by maintaining their laboratory instrumentation in an operational, qualified state. This entails ensuring both instrument hardware and software qualifications are completed in a timely manner and keeping them in a qualified state.
A typical day might include, but is not limited to, the following:
* Coordinating lab equipment installation process including procurement approvals
* Coordinating activities relating to the qualification, calibration, and maintenance of laboratory equipment and related systems
* Reviewing / approving qualification and validation documents as needed
* Scheduling and coordinating all preventive maintenance and repair work performed by outside contractors (includes ensuring vendors are in compliance with site requirements prior to performing equipment related services)
* Ensuring qualification, maintenance and repair activities are communicated to and scheduling occurs with the affected QC functional area
* Reviewing vendor documentation in support of qualification, preventative maintenance and repair work
* Ensuring the timely submission of work order requests for QC equipment and that scheduled work is completed appropriately
* Initiating, tracking and closing work records in BMRAM equipment database as needed
* Supporting change control activities impacting QC equipment; providing impact assessments when required
* Performing investigations of equipment related deviations as needed
* Participating in lab maintenance activities as needed
* Complying with all pertinent regulatory agency requirements
* Writing and revising equipment related SOPs as necessary
This role might be for you if:
* You have current or prior experience working with instruments in a regulated environment
* You have a proven ability to work independently or as part of a team
* You possess strong trouble-shooting and problem solving skills
* You have strong attention to detail and excellent written and oral skills
To be considered for this opportunity you should hold a BS/BA in Chemistry, Life Sciences, Engineering, or related field preferred; will substitute relevant experience for education.
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