Temp QC Compliance Analyst
Support the QC organization in meeting compliance targets through laboratory investigation and deviation management.
Key Responsibilities
* Authoring and peer reviewing of failure investigations/deviations relating to QC operations, including NOE, EOE, 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 spanning the entire QC department and coordinating 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, including SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
Requirements
Bachelor's degree in Life Sciences or equivalent with relevant experience, preferably in the pharmaceutical or biotechnology industries.