What are the responsibilities and job description for the QA Documentation Specialist I position at TekWissen LLC?
Job Description
Job Description
Overview :
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
Job Title : QA Documentation Specialist I
Location : Vacaville, CA, 95688
Duration : 5 Months
Job Type : Contract
Work Type : Onsite
Job Description :
We are seeking a highly motivated and experienced Quality Systems Support Specialist to join our team in Vacaville, CA.
In this role, you will provide essential support to the Quality System Management process with document control and PQS integration, ensuring compliance with cGMP and global requirements.
Key Responsibilities :
Support the implementation, execution and maintenance of the PQS integration and Quality Documents in Veeva at the Vacaville site.
Support PQS integration by working with the Quality Document control group to complete workflows, document gating and coordinate elements of the document change process to ensure minimal disruption to site operations
Support Quality Documents by :
Initiating and management of documents in Veeva Quality Docs.
Formating and editing of control documents
Track and log request of source documents
Ensure all activities are conducted in compliance with cGMP and global requirements.
Strive to maintain the highest level of inspection readiness at all times
Key Requirements :
1-3 years of experience in Quality within the pharmaceutical or biopharmaceutical industry, preferably within a supplier quality function.
Ability to effectively collaborate within a diverse, cross-functional team.
On-site presence at the Vacaville location is required.
Preferred experience with Veeva Quality Document Management System and Microsoft Teams.
Preferred Technical writing experience
TekWissen Group is an equal opportunity employer supporting workforce diversity.
