Data Reviewer, Quality Control

Avid Bioservices•Tustin, CA

32d•$27 - $36

About The Position

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Data Reviewer, Quality Control's main responsibility will be to review Quality Control analytical data.

Requirements

Bachelor's degree, preferably in a life sciences field (such as biology, microbiology, biochemistry, chemistry).
4+ years' work experience in a GMP/biopharmaceutical/pharmaceutical manufacturing environment.
Experience with Empower and SoftMax Pro software.
Knowledge of cGMPs, pharmacopeia and compendial requirements.
Experience in and knowledge of 21 CFR data integrity requirements.
Familiarity with analytical testing methods and validation including laboratory instrumentation.
Strong verbal and written communication skills.
Familiarity with laboratory computerized systems such as Empower and LIMS.
Proficient with Microsoft applications.

Responsibilities

Conduct a comprehensive and critical evaluation on QC data in Empower and SoftMax Pro software including but not limited to contents, results, data accuracy, and scientific relevance, format and adherence to cGMPs.
Perform a thorough review of raw data, including electronic raw data and documentations to ensure compliance with applicable specifications and/or protocols.
Conduct GMP review of laboratory notebooks, logbooks, and associate forms.
Conduct GMP review of electronic raw data to ensure compliance with data integrity policies.
Support OOS/OOT investigations.
Support internal and external audit.
Support QC method validation review, as needed.
Perform review of procedural and method revisions, where necessary.
Perform other duties as assigned to support Quality activities.