GxP Document Control Specialist
- Contract
- Good Clinical Practice (GCP)
- United States
This vacancy has now expired. Please see similar roles below...
GxP Document Control Specialist - Contract - New Haven, CT
Proclinical is seeking a GxP Document Control Specialist for our client based in New Haven, CT.
Primary Responsibilities:
The successful candidate will serve as the primary point of contact for on-site GxP records archiving. This role involves managing GxP archives, including receiving and logging archive requests, retrieving records from internal customers, and coordinating with our records vendor to archive records. The specialist will also manage the Enterprise Archiving & Retention business-process and associated processes, and provide excellent customer service support for service requests related to ECMS, Document Management processes, Audit and inspection requests.
Skills & Requirements:
- 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.
- Experience in developing, implementing, and evaluating archives or records management processes and systems.
- Ability to catalog, file, and retrieve records, and create and manage record retention schedules.
The job title responsibilities will be:
- Manage GxP Archives.
- Handle the Enterprise Archiving & Retention business-process and associated processes.
- Manage Lab Notebook/Logbook processes in collaboration with the Analytical Sciences lab onsite.
- Verify controlled documents within the Veeva Vault Quality Enterprise Content Management System (ECMS) for compliance to procedures.
- Provide customer service support for service requests related to ECMS, Document Management processes, Audit and inspection requests.
- Serve as a subject-matter-expert (SME) for Document Management, ECMS, Good Documentation Practices/ALCOA+, Data Integrity/Data Compliance, and other areas as assigned.
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDCQA
Related jobs
Highly Competitive
City of London, England
Proclinical is currently working alongside a pharmaceutical company to recruit for a Senior Quality Specialist & RPi. This is a permanent position based in London, United Kingdom.
US$190000 - US$220000 per annum
San Diego, USA
Proclinical is currently working to recruit for a Director / Senior Director, Head of Quality Assurance (GCP/Clinical Quality). This position is based in San Diego, California.
Highly Competitive
Cambridge, USA
Proclinical is working alongside a pharmaceutical company to recruit for a Quality Systems Specialist. This is a temporary contract position based fully remote, anywhere within United States.
Highly Competitive
Wiesbaden, Deutschland
Proclinical sucht einen Qualitätskontrollkoordinator IVD zur Verstärkung unseres Teams in Deutschland.
Highly Competitive
Basel, Schweiz
Proclinical is seeking a Quality Assurance Manager to join our client's team in Basel, Switzerland.
Highly Competitive Salary
Cambridge, USA
Proclinical is seeking a Clinical Trial Quality Oversight Specialist to ensure excellence in clinical trial delivery through robust quality systems.
Highly Competitive Salary
Philadelphia, USA
Proclinical is seeking a Senior Director of Quality Control to lead bioanalytical quality control operations for clinical and commercial cell therapy programs.