Quality Assurance Specialist
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Overview
Remote
On-site
Compensation
$35-$40/hour
Job Description
Title: Quality Assurance Specialist III Location: New Haven, CT (Hybrid, 3days onsite, 2 remote) Duration: 12 Months Pay Range: $35/hr. - $40.04/hr. Position Summary 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, Client 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.
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FAQs About Quality Assurance Specialist Jobs at Artech LLC
What is the work location for this position at Artech LLC?
This job at Artech LLC is located in New Haven, CT, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Artech LLC?
Candidates can expect a pay range of $35–$40 per hour for this role.
What employment applies to this position at Artech LLC?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Artech LLC?
You can apply for this role at Artech LLC either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.