Skip to content
QC Analyst
| Company | Sanofi |
|---|
| Location | Framingham, MA, USA |
|---|
| Salary | $67500 – $97500 |
|---|
| Type | Full-Time |
|---|
| Degrees | Bachelor’s, Master’s |
|---|
| Experience Level | Junior, Mid Level |
|---|
Requirements
- Bachelor’s Degree in Life Sciences discipline and 4-years’ experience in cGMP lab environment, or
- Master’s Degree in Life Sciences discipline and 2-year experience in cGMP lab environment.
- Proficient in Outlook and Microsoft Word and Excel and LIMS/lab-based data management systems.
- Experience in GMP Pharmaceutical/Biologics
- Experience with performing comprehensive data review
- Effective skills in time management, organization, teamwork, collaboration, and leadership.
Responsibilities
- Review QC Data for compliance to procedures and specifications, and current cGMPs.
- Perform expert and comprehensive data review to support routine QC and Manufacturing operations, investigations, and product lot release.
- Experience in testing and reviewing compendial QC Assays i.e., HPLC, UPLC, ELISA, gels, A280, Biocore, etc.
- Demonstrate proficiency in understanding and applying Good Documentation Practices, cGMPs, and Good Laboratory Practices in a Quality Control Laboratory.
- Data entry and filing of documentation, maintenance of laboratory testing files, and archiving of test records and logbooks.
- Demonstrate proficiency and adaptability of working with different Quality Control LIMS software systems.
- Create weekly metrics to assess, evaluate, and ensure occurrence of timely data review for all assays.
- Escalate issues identified during review, driving investigations and cross functional meetings (i.e. Gembas).
- Maintain and Perform Logbook Reviews.
- Interact with different departments to support timely and accurate data review for all assays.
- Collaborate on Quality Control method investigation and corrective action implementation.
- Work effectively with others to achieve shared goals.
- Revise procedure/ drive the SOP revision process.
- Provide on the floor (OTF) support to the operations department.
- May provide training to new employees.
- Support internal and external audit activities and conduct walkthrough inspections.
Preferred Qualifications
- Knowledge/Experience with scientific and technical writing
- Experience with compendial QC methods and global compendia requirements
- Knowledge and experience with discrepancy investigation and lot disposition to meet regulatory requirement
- Experience with Empower audit trail, Lab Data Management systems
