Data Reviewer, Quality Assurance

Description

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 Assurance’s main responsibility is to confirm values and statements made in draft reports/documents matches the primary source data and flag any information which does not align between the draft report and the primary source. The ability to identify and escalate issues as needed, maintain an organized work environment, and manage multiple reviews in parallel. The QA Data Reviewer will have multitasking skills and an attention to detail.

Key Responsibilities:

• Perform a thorough review of data, including electronic data and documents to ensure compliance with applicable specifications and/or protocols
• Conduct GMP review of Validation/Qualification Protocols, Reports, and other GMP documents for data correctness.
• Conduct GMP review of Method Validation, Test Methods, and associated forms.
• Conduct GMP review of electronic data to ensure compliance with data integrity policies.
• Support data verification of OOS/OOT investigations, as assigned.
• Support data verification of QE investigations, as assigned.
• Support review of procedural and method revisions, as assigned.
• Performs 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.
• Knowledge of cGMPs, or equivalent regulations is preferred
• Experience in and knowledge of 21 CRF data integrity requirements.Skills to independently evaluate situations and propose potential solutions.
• Excellent technical writing and editing skills

Position Type/Expected Hours of Work: 

This role is a full-time onsite position. Days and hours of work are Monday through Friday 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

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 $32.69 - $40.86 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 25 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.