Data Reviewer, Quality Assurance

Avid Bioservices•Tustin, CA

14h•Onsite

About The Position

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. 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.

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.
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
Exceptional multitasking skills and an unparalleled attention to detail
Master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Nice To Haves

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.
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.

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