Compliance Specialist QC
About this role
Within this role you will support QC compliance by managing deviations, investigations, change controls, and CAPAs. Coordinate cross-functional activities, track and report quality system metrics, and drive continuous improvement to meet cGMP and regulatory expectations.
As an Compliance Specialist QC, a typical day might include the following:
Authoring and peer-reviewing QC laboratory investigations and deviations, including NOE, EOE, DNF, and GLIF investigations
Leading and documenting corrective and preventive actions (CAPAs) and change controls
Coordinating cross-functional teams during change control/CAPA events and deviations and align on action plans
Reviewing, editing, and revising controlled documents (e.g., SOPs, logbooks) to ensure cGMP compliance
Creating and maintaining QC quality records and workflows; ensure timely, accurate documentation
Tracking and maintaining status of open QC compliance records (deviations, CAPAs, change controls, workflows)
Compiling and reporting quality system metrics to QC leadership and stakeholders
Conducting cross-functional laboratory investigations across QC; coordinate resources from multiple departments
Representing QC in interdepartmental meetings and cross-functional forums
Driving continuous improvement in laboratory investigation practices and quality system processes
Supporting and participating in regulatory inspections
Performing other tasks as assigned by the Manager
This role may be for you if you:
Train and mentor compliance team members
Take increased ownership for authoring, reviewing, and approving documents and data
Represent Compliance in cross-functional site meetings
Perform advanced technical writing (SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations)
To be considered for this opportunity you should have a BS/BA in Life Sciences or equivalent, preferably with experience in pharmaceutical or biotechnology industries.
Education & Experience:
Associate Compliance Specialist (QC): 0-2 years of relevant experience
Compliance Specialist (QC): 2 years of relevant experience