Quality Control Data Reviewer

The role

The Quality Control Data Reviewer supports Quality Control laboratory operations. This person verifies that analytical data and reports are accurate, complete, traceable, and compliant before results are released.

What you will do

• Review Quality Control data and analytical reports for compliance with specifications and GMP requirements.
• Review chromatographic data, laboratory notebooks, and sample results for accuracy and traceability.
• Review equipment and instrument logbooks for accuracy and compliance.
• Verify audit trail records and assess electronic data for compliance with 21 CFR Part 11.
• Document and communicate data review findings and deficiencies.
• Conduct and document laboratory investigations regarding data discrepancies and laboratory events.
• Report non-conformances and data integrity concerns to Laboratory Management.
• Review and revise applicable SOPs and laboratory procedures.
• Perform document control activities including issuance of notebooks and archival of records.
• Serve as a Subject Matter Expert for Quality Control data review processes.

Required qualifications

• Minimum BS in Chemistry, Biology, Pharmaceutical or related sciences
• At least four to five years of laboratory experience
• Knowledge of current United States Pharmacopeia and National Formulary (USP-NF)
• Working experience in Deviations, CAPA and out-of-specification (OOS) investigations utilizing root cause analysis tools
• Basic understanding of Quality Management System i.e. Veeva
• Must be able to work independently with limited direct supervision
• Good written and verbal communication skills
• Must be computer literate, working knowledge of the basic hardware, software, internet including word and excel
• Must be able to maintain a safe working environment and follow safety procedures

Nice to have

• Previous data review experience with Chromeleon, HPLC, GC, FTIR etc.

About the company

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. It is an entrepreneurial company with a commitment to innovation and patient access to affordable medicines.