What are the responsibilities and job description for the Biomanufacturing Quality Assurance - Data Migration position at Randstad Enterprise?
Randstad Enterprises is a true partner for talent that creates successful end results for both their client and the talent they hire. In this role, you will have an opportunity to work in a well respected Biotechnology company AND have the support needed to guide you towards success in Randstad.
Initially a 6-month contract with possibility of extension, dependent on needs and performance
100% onsite at the clients facility in RTP, NC 27709
Mon – Fri, standard work weeks and hours with occasional overtime as needed
Quality Assurance Associate - EMS Migration
Supporting Large Scale Manufacturing (LSM) during a modernization project in a migration to a new Manufacturing Execution System (MES). Your main strength is the ability to predict and troubleshoot potential issues before they arise. There will be several phases :
Electronic equipment tracking
Electronic batch records
Release by exception functionalities
Special focus will be testing to ensure the site is ready to receive and sustain the changes to the routine production operations.
Responsibilities
Work within the internal QA group supporting documentation creation, update, reviews, provide meeting support, support design questions making recommendations on improvements, compliance where appropriate.
Support batch record traceability mapping activities in addition to other assignments as required by group management.
Collaborate with project teams, contractors, and site operations staff.
Qualifications and Skills
Experienced QA associate within a large molecule, drug substance facility
5 years of experience within the pharmaceutical, biotech industry
Regulatory requirements in the pharmaceutical industry (FDA, EMA)
Able to manage multiple tasks simultaneously in a fast-paced environment
Experience working within a matrix teams’ environment
Documentation supporting a newly designed / validated MES system
NEEDED FOR SUCCESS : experience working on or with Manufacturing Electronic Systems (MES) or electronic batch records implementation projects
MUST HAVE - proficiency in myCIMS or Veeva document management systems a plus
Education
Bachelor’s degree in science, engineering, or other technical field of study
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