Quality Control Data Review Specialist - GMP , Chromatography

Responsibilities

• Performs detailed review and approval of all types of data and documents (e.g. protocols, reports, and test procedures).
• Affords assistance in maintaining process KPIs and quality matrix as required.
• Drives alignment of the process with quality and compliance procedures.
• Serves as an effective member of the Laboratory Operations team and may serve as a mentor to other employees in the area of expertise.
• Carries out floor inspections with focus on audit trail review and testing process/technique scrutiny as required.
• Provides support to release of materials (e.g. media, reagents) as required.
• Affords assistance to continued improvement initiatives as needed.
• Affords assistance in the development/writing of SOPs, Work Instructions, and other documents and/or reports as needed.
• Complies with company policies and SOPs.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Qualifications

• Bachelor’s degree in Chemistry, Biology, or related field with 2+ years GMP related experience; OR Master’s degree in related field with 1+ years related experience; OR equivalent education and work experience.
• Preference to those with Bachelor’s degree in Chemistry, Biology, or related field with 5+ years GMP related experience; OR Master’s degree in related field with 4+ years related experience; OR equivalent education and work experience.
• Chromatography experience required.
• Method validation experience preferred.