What are the responsibilities and job description for the Senior Quality Control Specialist, LIMS position at Planet Pharma?
Overview
The Senior Quality Control Specialist, LIMS role is responsible for deployment and administration of the QC Laboratory Information Management System (LIMS). This role represents QC in the development, configuration, validation, implementation and maintenance of the LIMS as it relates to QC functionality including analytical and microbiology testing, environmental monitoring, raw materials, critical reagents, stability and sample management to support compliance with regulatory requirements and commitments for clinical and commercial products.
This individual has a good understanding of, and experience with LIMS within a cGMP-regulated environment. The position reports to the Director, Quality Control Compliance.
Essential Functions and Responsibilities
- Understand and execute change management in a GMP environment and drive changes through appropriate quality system. Own changes, as required.
- Support deviations and LIR’s with LIMS information, as needed.
- Collaborate with stakeholders to develop the requirements and the long-term vision for LIMS.
- Drive development and implementation of the LIMS by partnering with IT and external vendors.
- Develop and regularly update key project information such as status, timelines, scope statements, budgets, resources, risks, issues, decisions, and action items.
- Manage enhancements, incident investigation, and changes for a multi-site, global LIMS
- Draft program related support documents including operational SOPs, Work Instructions, System Impact assessments, change controls, as needed.
- Track and resolve LIMS support program issues and identify potential enhancements to the system.
- Independently plan, manage and execute assignments, contribute to project planning meetings.
- Support product stability programs including generation of stability protocols in LIMS, and support as needed accessing final reporting or trending of stability data
- All duties are performed with minimal supervision and oversight
- Must adhere to core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
- Bachelor’s degree in a relevant discipline (biological sciences, computer science or equivalent)
- Minimum of 5-10 years of experience in a cGMP laboratory including at least 3 years as a LIMS administrator. Experience with configuring and implementing a LIMS
- Experience with translating business documents (batch records, test methods, stability protocols) into technical requirements and configuring in a LIMS solution.
- Ability to manage external partners with respect to technical support activities
- Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.
- Problem solver who not only identifies issues but leads efforts to resolve them
Preferred Education, Skills, and Knowledge
- Experience with cell and/or gene therapy products is a plus.
- Experience with MS SQL Server or Oracle database is a plus.
