This position will support the Large-Scale Manufacturing (LSM) Modernization project for bringing a new Manufacturing Execution System (MES) to the drug substance manufacturing area. This system will encompass several phases covering electronic equipment tracking, electronic batch records and release by exception functionalities. This role will be supporting the operational readiness workstream and activities associated with ensuring the site is ready to receive this change and sustain it within routine production operations.
location: Durham, North Carolina
job type: Contract
salary: $23 - 33 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- The Quality Assurance (QA) project support role will be responsible for assisting in daily activities related to the internal large-scale manufacturing (LSM) modernization project bringing MES and electronic batch record implementation to the site.
- This role will work with the internal QA group to support 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.
- This role requires a strong background in quality and understanding of regulations and requires a strong understanding of drug substance manufacturing and documentation processing within a digital document management system.
- This role will interact with the newly designed / validated MES system and the associated documentation supporting these systems.
qualifications:
Required
- Bachelor's degree in science, engineering, or related discipline.
- If no Bachelor's degree, must have 5-10 years of quality operations experience within the pharmaceutical, biotech industry.
- Experience working in a large molecule, drug substance facility.
- Experience working on or with Manufacturing Electronic Systems (MES) or electronic batch records implementation projects.
- Familiarity with regulatory requirements in the pharmaceutical industry (Example: FDA, EMA).
- Proficiency in myCIMS or Veeva document management systems.
- Experience with data migration from paper to electronic systems.
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
