What are the responsibilities and job description for the Quality Systems Specialist (LIMS) position at Unicon Pharma Inc?
About the Role
We are looking for a LIMS Specialist to support the implementation and operation of a Veeva LIMS system at a biotechnology manufacturing facility. You’ll work closely with Quality Control, IT, and lab teams to ensure smooth laboratory operations and data integrity.
Responsibilities
- Develop and maintain LIMS procedures, documentation, and user guides
- Configure, troubleshoot, and support LIMS workflows
- Act as the main point of contact for LIMS-related issues
- Implement system updates and ensure compliance (GxP, 21 CFR Part 11)
- Manage sample workflows and study setups
- Train users and provide ongoing support
- Support audits, inspections, and documentation needs
- Ensure data security, access control, and backups
- Collaborate with cross-functional teams on lab initiatives
Qualifications
- Bachelor’s degree in Science, Chemistry, or related field
- 3–5 years of experience in pharmaceutical or cGMP environments
- 1–3 years of LIMS experience (Veeva LIMS preferred)
- Experience with lab instruments (HPLC, GC, etc.)
Required Skills
- Strong problem-solving and communication skills
- Ability to work independently and in team settings
Preferred Skills
- Experience with radiopharmaceuticals or injectables
- Knowledge of root cause analysis tools (5 Whys, Fishbone, etc.)
- Experience with other LIMS platforms (e.g., LabWare)