Position OverviewHelp build and optimize a best-in-class LabWare LIMS v8 environment that powers Quality Control in a GMP setting. As Sr. Specialist 1, QC LIMS, you'll configure, validate, and sustain a critical system that enables compliant, efficient testing-directly impacting product quality and patient safety.
Job DescriptionAbout Us
We are a collaborative Quality Control LIMS team partnering closely with Quality Control, Analytical Development, Manufacturing, IT, and Quality Assurance. Our mission is to ensure our LabWare LIMS operates in a robust, validated, and compliant state aligned with cGMP, ICH, FDA, 21 CFR Part 11, and GAMP expectations. We value curiosity, accountability, and cross-functional partnership, and we foster an inclusive environment where every voice is heard and respected.
Minimum qualifications (must-have)
- Bachelor's degree in Computer Science, Information Technology, Biology, Microbiology, Biochemistry, or a related scientific discipline with 2+ years of experience; or
- Master's degree in the same fields with 0 years of experience
- Ability to function in a fast-paced, highly technical environment
- Demonstrated ability to work cross-functionally and build strong partnerships across levels (management, laboratory personnel, plant personnel)
- Thorough knowledge of cGMP/ICH/FDA regulations; familiarity with 21 CFR Part 11 and GAMP
- Strong verbal and written communication, technical writing, and problem-solving skills
- Understanding of pharmaceutical/biotech testing cycles or requirements
- Ability to work effectively with diverse teams
Preferred qualifications (nice-to-have)
- 1-3 years of experience in a cGMP Quality Control department or FDA-regulated industry (drugs/biologics)
- Previous experience with LabWare LIMS development or other LIMS software development
- Experience with 21 CFR Part 11 and GAMP (applied/working experience)
- TrackWise (or similar quality system) experience for at least 1 year
- Leadership aptitude
Responsibilities
- Participate in the LabWare LIMS v8 site go-live, including static data migration, configuration, validation, and cross-functional coordination to ensure a successful rollout.
- Collaborate with business subject matter experts to define and document new or revised LabWare requirements.
- Configure basic and advanced LabWare LIMS objects, including:
- Specifications, Analyses, Batch Templates, Test Lists, QC Samples
- Calculations, Format Calculations
- Templates (Stability, Sample Login, Standards, Reagents)
- Execute qualification/verification testing to support implementation of new or revised LabWare configurations.
- Maintain and, when needed, repair configuration objects within LabWare LIMS.
- Create queries to support evolving business requirements.
- Use the change management system to update configurations for specifications, analyses, and other static data in LIMS.
- Provide timely user support and troubleshooting; create new configuration templates; maintain accurate change records per version control procedures.
- Deliver LIMS training, technical support, problem reporting, and resolution for QC, QA, AD, and Manufacturing teams.
- Evaluate LIMS data to provide ad hoc and long-term reporting solutions; identify process gaps and propose improvements.
- Write test scripts for new LIMS functionality and participate in validation of new functionality/releases.
- Develop and maintain process configurations based on end user procedures and requirements.
- Partner with the LIMS team, IT, and end users to ensure new functionality meets user requirements.
- Create and revise LIMS documentation: SOPs, Work Instructions, Design Specifications, and training materials.
- Support LIMS platform expansion by preparing and executing validation test scripts.
- Liaise with laboratory end users to ensure configuration changes meet user needs.
- Revise or develop Functional Requirement Specifications (FRS) and User Requirement Specifications (URS), plus other relevant documentation.
- Perform other related duties as assigned.
Work environment and physical requirements
- Ability to sit for prolonged periods (approximately 240 minutes daily); perform repetitive motions with wrists/hands/fingers.
- Ability to lift/move objects up to 10 lbs.
- Ability to discern audible cues and perform tasks requiring 20/20 corrected vision, including color differentiation.
- No routine requirement for respiratory protection, working at heights, operating motor vehicles/PITs, or working in extreme temperatures.
Benefits We offer a competitive, comprehensive benefits package designed to support your well-being and growth. Highlights typically include:
- Competitive compensation with performance recognition
- Medical, dental, and vision coverage
- Retirement savings plan with company contribution
- Paid time off, company holidays, and paid parental leave
- Education assistance, professional development, and training
- Employee assistance program and wellness resources
- Inclusive culture with employee resource groups and opportunities to contribute to continuous improvement
