Author Assistant Jobs in Raleigh, NC (NOW HIRING)

Company Description

IRI believes in commitment, Integrity and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.

Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.

Job Description

Experience in a sterile or pharmaceutical environment is required but will consider other FDA -- cGMP experience and medical device or combination product production

Performed validation of Quality Control laboratories instruments (with and without computer systems) according to the site's applicable validation SOPs.

Authors validation deliverables as required.

Ensure that the system is installed and configured in a 21 CFR Part 11/Annex 11 compliant manner.

Provide validation expertise and support to the Quality Control laboratories.

At least 4 years' experience validating equipment

At least 2 years' experience validating laboratory instruments with computer systems

Initiates and leads change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software where applicable in Quality Control laboratories.

Authors cGMP risk assessments, user requirements and function specifications, validation plans, protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation deliverables as required by the site validation SOPs. Previous experience with validation of laboratory instrument systems preferred.

Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.

Assist the system owner with evaluating recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and preventive maintenance plans.

Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument.

Previous experience with PR/CAPA systems preferred.

Ensures lab instrument's adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines. Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence. For systems found unable to fully comply, formulate workarounds/strategies to mitigate the gaps.

Initiates and leads risk assessment, gap analysis, and deviation management associated with validation of lab instruments.

Support and assist teammates wherever possible.

Perform other related duties as assigned or required.

Quality Laboratories Subject Matter Experts for the respective instruments

Quality Laboratories System Owners for the respective instruments

Quality Laboratories System Super Users (if applicable) for the respective instruments

Instrumentation Team (if applicable) for instrument calibration

Additional Information

Regards,

Indu
Clinical Recruiter
732-844-8725 

indu @irionline.com