Job Title: Temp QC Compliance Analyst
About the Role:
This position plays a vital role in supporting the QC organization 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.
A Typical Day as a Temp QC Compliance Analyst
* Authoring and Peer Reviewing of Investigations: Prepare and review 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: Provide quality system metrics to the group and other QC functions.
* Cross-Functional Laboratory Investigations: Conduct cross-functional laboratory investigations spanning the entire QC department and coordinate resources from multiple departments.
* Representative for QC: Represent QC on interdepartmental teams and in meetings.
* Continuous Improvement: Strive for continuous improvement in Laboratory Investigations practices to foster compliance and meet different regulatory expectations.
* Regulatory Inspections: Participate in regulatory inspections as required.
* Ongoing Tasks: Complete other tasks as directed by Manager.
Additional Responsibilities
* Training Employees: Increase involvement in the training of employees.
* Document Authoring: Increase responsibilities for authoring and reviewing documents/data.
* Compliance Representation: Represent QC in cross-functional site meetings.
* Technical Writing Assignments: Perform technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
Requirements:
To be considered for this opportunity, you should have a BS/BA in Life Sciences or equivalent with relevant experience, preferably in the pharmaceutical or biotechnology industries.