Position: US System Analysis & Consulting Expert 1 / Analytical Data Specialist (MEWPJP)
Duration: 09 Months (High Chances of Extension or Conversion)
Location: Saint Louis MO 63118
Job Description:
Top 4 Must have Skillset:
- Candidates must have 35 years of experience in an analytical role
- Bachelors degree required (science or analytical/technical background)
- Heavy data entry
- Lab Vantage preferred
Role responsibilities:
- Responsible for creating review and approve product/master builds in LIMS per 21CFR Part 11 & EU Annex 11 guidelines and regulations including appropriate data integrity.
- Included in the introduction of product/master builds the individual will support by reviewing applicable documentation and make revisions and changes as required.
- Additionally the individual will act as a software administrator for LIMS software when requested not including management of user accounts and roles.
- The individual will also assist in the investigation of deviations as needed.
Education requirements:
- BS or MS degree life sciences
Work experience requirements:
- 35 years of GMP experience in pharmaceutical biopharmaceutical or chemical industry
- Prior experience with analytical testing preferred.
- Prior data entry experience recommended.
Role Specific Competencies & Skills:
- Familiarity with general laboratory instrumentation and documentation.
- Working knowledge of laboratory management systems Lab Vantage LIMS preferred.
- Prior Instrumentation testing experience is preferred
- Able to excel in a team setting in a dynamic environment where shifting priorities are common.
- Strong verbal and written communication skills.
- Ability to work independently.