Quality Quality Assurance Specialist - Hybrid New Haven, CT (3x onsite per week) New Haven, Connecticut
Orbis Clinical is seeking a Quality Assurance Specialist located in New Haven, CT (Hybrid) for 12 months.
Job Title: Quality Assurance Specialist
Location: New Haven, CT Hybrid (3x onsite per week, 2x remote)
Contract: 12 months
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.
Qualifications
- 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.
Compensation Details:
- Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
- The Pay Range for this position is $38.62 per hour, can vary depending on employment status.
- Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).
EEO and Reasonable Accommodation Statement:
Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.
By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
