As a Temp QC Compliance Analyst, you will 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 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
In addition to these responsibilities, analysts may also be involved in:
* 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.
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.
We value diversity and inclusion at our company and are an equal opportunity employer. We will consider all qualified applicants without regard to race, color, religion, sex, nationality, national or ethnic origin, age, citizenship status, disability, or any other protected characteristic.