Quality Assurance Specialist
Talent Groups ·www.talentgroups.com
Apply direct
Hybrid Details: Onsite 3 days/week
Duration: 12 months to start
Job Description
This role is responsible for ensuring quality and compliance of active GxP documentation and archived GxP records, as well as providing administrative support, technical and process-expertise, quality assurance, and general consulting as needed.
Principal Responsibilities
Areas of responsibilities include, but are not limited to:
Duration: 12 months to start
Job Description
This role is responsible for ensuring quality and compliance of active GxP documentation and archived GxP records, as well as providing administrative support, technical and process-expertise, quality assurance, and general consulting as needed.
Principal Responsibilities
Areas of responsibilities include, but are not limited to:
- Serving as the primary Point-Of-Contact for on-site GXP records archiving at the New Haven, CT site.
- Managing GXP Archives at the New Haven, CT site including receiving and logging archive requests, retrieving Records from internal customers, and coordinating with Records vendor/supplier to retrieve and archive records.
- Managing the Enterprise Archiving & Retention business-process and associated processes with direction from the Manager, Documentation Services.
- Managing Lab Notebook/Logbook processes in collaboration with the Analytical Sciences lab onsite.
- Performing verification of controlled documents within the Veeva Vault Quality Enterprise Content Management System (ECMS) for compliance to procedures.
- Providing excellent customer service support for service requests related to ECMS, Document Management processes, Audit and inspection requests, and collaborating with document owners/authors for any ECMS documentation related queries.
- Serving as a subject-matter-expert (SME) for Document Management, ECMS, Good Documentation Practices/ALCOA+, Data Integrity/Data Compliance, and other areas as assigned.
- 4 - 6 Years’ Experience within Document Control (processing, verification, and archiving); Quality Assurance, Quality Systems, or related role in a GxP-regulated biopharma, medical device, or similar industry.
- Bachelor’s degree required (Science preferred, Business and other disciplines considered).
- Experience with electronic QMS applications including Veeva Vault Quality, TrackWise, ServiceNow, FirstDocs, Microsoft Office Applications, etc.
- Ability to work independently under minimum supervision.
- Experience in developing, implementing, and evaluating archives or records management processes and systems. This includes cataloging, filing, and retrieving records, and creation and management of record retention schedules.
- Experience with GMP global regulatory requirements.
- Knowledge of archival metadata and metadata management.
- Ability to work in a fast-paced environment.
#LI-Hybrid
Frequently asked questions
Who is hiring for the Quality Assurance Specialist role?
Talent Groups is hiring for the Quality Assurance Specialist position, a Shazamme client. Apply directly on the employer's career site.
Where is the Quality Assurance Specialist job located?
The Quality Assurance Specialist role with Talent Groups is based in New Haven, CT, US. The role is hybrid-friendly.
Is the Quality Assurance Specialist role remote?
Yes — the Quality Assurance Specialist position at Talent Groups is hybrid. Candidates based in US are preferred.
What does the Quality Assurance Specialist role pay?
Talent Groups lists the Quality Assurance Specialist role at USD 28–38 per hour.
Is the Quality Assurance Specialist role full-time or contract?
This is a full time position at Talent Groups.
What experience level is the Quality Assurance Specialist role?
The Quality Assurance Specialist position is aimed at mid-level candidates.
How do I apply for the Quality Assurance Specialist role at Talent Groups?
Apply directly on Talent Groups's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.