QA Data Reviewer I

Performs critical in-depth review of all scientific data for Quality Control laboratory documents under general supervision.

Area Of Responsibility

• Performs critical in-depth review of all scientific data for Quality Control laboratory documents (including, but not limited to review of raw data of in-process, API / Excipients, Finished Products, Stability, Cleaning Verification, Instrument calibration records, Contract laboratory results notebooks, reports, and materials for ANDA submissions) for completeness, integrity and accuracy.
• Demonstrates a thorough knowledge of approved SOP’s, compendia (USP, BP, and EP), ICH, FDA and other regulatory guidances.
• Ensures that all documents are in compliance with cGMPs and the site operating procedures under the direction of QA management.
• Supports systems to ensure the successful completion of Departmental goals and objectives.
• Other tasks as assigned by the Manager.

Work Conditions:

• Lab Environment

Physical Requirements:

While performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle objects, or feel objects, tools, or controls; and reach with hands and arms. The employee is occasionally required to visit lab environment, stand, and stoop, kneel and crouch specific vision abilities required of this job include close vision, distance vision, color vision and the ability to adjust focus. The employee must regularly lift and / or move up to 10 pounds.

Education and Job Qualification

• Minimum of a Bachelors
• Knowledge of pharmaceutical analysis.
• Ability to review laboratory records with minimal supervision within the framework of cGMP / GLP for analytical laboratories.
• Good understanding of EHS and OSHA safety guidelines.
• Knowledge of USP, ICH, FDA, and DEA regulations.
• Knowledge of the operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.
• Demonstrated excellent communication : verbal, written and presentation skills.
• A self-starter with a hands-on approach and a can-do attitude.
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Experience

• Minimum of three years of experience in a pharmaceutical environment with a minimum two years of experience in chromatography (e.g. HPLC with empower data acquisition software, GC, FTIR, UV and wet chemistry).