8537 Senior EQ QC Associate

Job Responsibilities
Support Equipment Qualification Lifecycle (Design, Instrumental, Operational, Performance, and
Decommissioning of QA approved protocols), collaborating with Quality to ensure timely release
of GMP equipment for validation/testing.
Coordinate equipment qualification and preventative maintenance activities.
Under Quality oversight and direct management and/or subject matter expert engagement,
provide technical assessment, user requirement specifications, and review data generated per
approved protocols.
Ensure that equipment and systems remain in a validated and/or maintained state and provide
support for equipment change orders and various administrative support duties.
Periodic audit of equipment maintenance logs, periodic archiving of equipment qualification and
maintenance documentation. per approved procedures.
Act as a Change Owner for EQ and Production activities related to the IMP QC Control System
strategy.
Support internal and external audits by supporting lab maintenance activities.
Participate in QC discrepancy assessments, investigations, method validation support and
present work at departmental meetings.
Perform equipment troubleshooting.
Work with internal departments and outside vendors, collaborators and partners concerning
projects and commitments.
Train EQ members, as needed on Equipment Qualification Lifecycle requirements.
Technical proficiency in analytical methodology and adherence to cGMP compliance.
Acquire quotes for instruments/equipment or vendor service and apply for credit application, if
Applicable.

Job Requirements:
BS/BA degree in life sciences, or equivalent.
Demonstrate excellent verbal and written communication skills, organizational skills; is detail-oriented, and has the ability to work effectively in a fast paced, multidisciplinary team environment with various projects and timelines.

PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.