Remote - Quality Control Documentation Specialist (Biotech)

Brio group is partnered with a biotech company that's currently hiring for a Remote Quality Control Documentation Specialist role. This is also a 6 Months renewable W-2 Contract opportunity.

Job Title: Quality Control Documentation Specialist (Remote)

Remote (West Coast, Central is preferred)

W2 Contract status

Looking for Biopharma/CRO industry experience

**Quality Control **

** Documentation**

** Contracts Management **

Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.

Position Overview:

we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Documentation Specialist, you will responsible for the organization, storage and retrieval of documents generated by Translational Sciences. Additionally, will be accountable for the maintenance of the department training system, assisting with electronic signing of training records and work with managers and Quality to track employee training for regulatory compliance. This person will manage, negotiate, and execute contracts supporting nonclinical outsourced activities, working as liaison between vendors and project team representatives.

What you’ll do

· Organize and file study and facility documents; ensure that documents retained are

appropriately indexed to permit expedient retrieval with appropriate access assigned

· Track timeliness of documents for review and approval, including facilitation of the review

processes of nonclinical study documents (ie., protocols, reports, and operating

procedures)

· Maintain updated CVs, job descriptions and training records electronically for employees in

Translational Sciences

· Communicate best practices and provide documentation training to employees as needed

· Maintain an index of materials archived internally and at CROs for all nonclinical studies

· Create and track sample manifests, ensuring archival in appropriate location

· Participate in data QC, status, and distribution of QC templates

· Assist and liaise with IT as needed to troubleshoot issues with documentation platform and

access

· Respond to requests to create study folders and provide study report templates in a timely

manner

· Circulate requested documents for signature via 21 CFR Part 11 compliant DocuSign to

support Translational Sciences

· Drive the execution of legal contracts – CDA/NDA, MSA, SOW and POs as needed by

Pharmacology and Toxicology investigators

· Contract life-cycle oversight - Review, process, and day-to-day management of a variety of contracts with select vendors

· Liaise with study teams, Legal and Finance functional groups for contract maintenance and tracking in contract management software

What we’re looking for

· Bachelors in a scientific discipline plus 2-3 years or equivalent combination of education and work experience preferably in a pharmaceutical industry

· Understands basic in vivo/in vitro study design principles and has worked in or understands nonclinical phase of drug development

· Effective communicator both verbally and in writing

· Must be detail oriented, with ability to multi-task and work cross-functionally with team members and team environments

· Excellent interpersonal, organizational, and problem-solving skills required to manage multiple tasks at different phases in parallel and track work and projects to meet timeline demands

· Proficiency with MS Office (Word, Excel, PowerPoint etc.) and a database system for storing and tracking documents or study samples

· Works on problems of diverse scope and demonstrates good judgment in problem-solving

· Ability to collaborate cross-functionally and be a strong team player

What will separate you from the crowd

· Familiarity with GDP, GLP regulations (CFRs, ICH), laboratory documentation, electronic laboratory notebook (ELN), and/or electronic document management system (EDMS)

· Familiarity with 21 CFR Part 11 compliance needs for electronic documentation, storage, and retrieval

· Familiarity working with contracts and or legal to put study agreements in place or similar translatable skills

We welcome the opportunity to provide a full job description upon resume review.

How to Apply:

In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.

We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.

Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.