Job Title: Temp QC Compliance Analyst
Overview
The Temp QC Compliance Analyst will support the QC organisation in meeting compliance targets through laboratory investigation and deviation management. The Compliance Analyst will report quality system metrics to the group and identify improvements that can be made in all quality system inputs.
Key Responsibilities:
* Authoring and peer reviewing of failure investigations/deviations relating to QC operations including: NOE, EOE and DNFA, GLIF investigation, corrective and preventive actions, change control and standard operating procedures.
* Reporting quality system metrics to the group and other QC functions.
* Conducting cross-functional laboratory investigations that may span the entire QC department and coordination of resources from multiple departments.
* Representing QC on interdepartmental teams and in meetings.
* Striving for continuous improvement in Laboratory Investigations practices to foster compliance and meet different regulatory expectations.
* Participating in regulatory inspections as required.
* Completing other tasks as directed by Manager.
Additional Responsibilities:
* Increasing involvement in the training of employees.
* Increasing responsibilities for authoring and reviewing documents/data.
* Compliance representation and participation in cross-functional site meetings.
* Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
Requirements:
A BS/BA in Life Sciences or equivalent with relevant experience, preferably in the pharmaceutical or biotechnology industries.