Job Title: Temp QC Compliance Analyst
The Temp QC Compliance Analyst will support the Quality Control organization in meeting compliance targets through laboratory investigation and deviation management. The analyst will report quality system metrics to the group and identify improvements that can be made in all quality system inputs.
A typical day for this role might include, but is not limited to, the following responsibilities:
Key Responsibilities:
1. Laboratory Investigation and Deviation Management: Authoring and peer reviewing of failure investigations/deviations relating to quality control operations, including NOE, EOE, and DNFA, GLIF investigations, corrective and preventive actions, change control, and standard operating procedures.
2. Quality System Metrics Reporting: Reporting quality system metrics to the group and other quality control functions.
3. Cross-Functional Laboratory Investigations: Conducting cross-functional laboratory investigations that may span the entire quality control department and coordinating resources from multiple departments.
4. Representation and Collaboration: Representing quality control on interdepartmental teams and in meetings.
5. Continuous Improvement: Striving for continuous improvement in laboratory investigations practices to foster compliance and meet different regulatory expectations.
6. Regulatory Inspections: Participating in regulatory inspections as required.
7. Additional Tasks: Completing other tasks as directed by the manager.
Additional responsibilities for analysts may include, but are not limited to:
Analyst Responsibilities:
1. Training and Development: Increasing involvement in the training of employees.
2. Document Review and Authorship: Increasing responsibilities for authoring and reviewing documents/data.
3. Compliance Representation: Compliance representation and participation in cross-functional site meetings.
4. Technical Writing: 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 an equivalent with relevant experience, preferably in the pharmaceutical or biotechnology industries.