Data Reviewer, Quality Control

United States·Tustinmid

OtherQuality Control

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Quick Summary

Overview

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.

Key Responsibilities

The Data Reviewer, Quality Control’s main responsibility will be to review Quality Control analytical data. In this role you will: Conduct a comprehensive and critical evaluation on QC data in Empower and SoftMax Pro software including but not…

Requirements Summary

You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way. Your written and verbal skills are out of this world, and you communicate with clarity and confidence.

Technical Tools

OtherQuality Control

Your Role:

The Data Reviewer, Quality Control’s main responsibility will be to review Quality Control analytical data.

In this role you will:

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.

Minimum Qualifications:

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.

Position Type/Expected Hours of Work:

This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. unless otherwise stated by Supervisor. Must be available to work holidays, weekends, or extended hours if needed.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $31.63-$42.16 hourly, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.