QC Data Senior Specialist
CooperSurgical · Livingston, NJ · 1 wk ago
On-siteQuality Assurance$105k–$115k/yrFull-time
Responsibilities
- Own the aggregation, standardization, and usability of QC and laboratory data sourced from LIMS, spreadsheets, QMS, and instrument outputs
- Perform routine data trending, SPC analysis, and statistical evaluations to identify shifts, emerging risks, or out-of-trend behavior
- Maintain and enhance existing laboratory data pipelines and SPC reporting tools to improve usability and operational relevance
- Identify inefficiencies or risks in spreadsheet- and pipeline-based workflows and drive standardization or automation improvements
- Support quality investigations, audits, and customer-facing data requests by compiling, organizing, and validating relevant QC and laboratory data in partnership with Supply Chain and Commercial teams
- Partner with R&D to support data analysis for method development, optimization, and validation activities
- Support LIMS implementation and optimization activities, including user acceptance testing, workflow validation, and post-go-live refinement
- Collaborate with IT and business partners to help define and improve laboratory data storage structures, data flows, and dashboards used for QC and leadership review
- Participate in QC testing, environmental monitoring, and equipment qualification activities as assigned
Qualifications
- Knowledge of laboratory SOPs, Certificates of Analysis, and other technical documents
- Advanced proficiency in Microsoft Excel and other Office applications
- Experience working with existing cloud-hosted data pipelines (e.g. AWS, Azure, or GCP)
- Understanding of laboratory data integrity principles (GDP, ALCOA+)
- Excellent written and verbal communication skills to collaborate across departments
- Experience partnering with IT and business analysts on data systems, reporting tools, or dashboards
- Previous experience working with LIMS platforms such as Sapio or LabVantage
- Comfortable with managing change in a dynamic lab environment with shifting priorities, new technologies, and growth demands
Education
- Bachelor’s degree in Biology, Molecular Biology, Bioinformatics, Engineering, Data Science, or related scientific/technical field
- PREFERRED: Graduate-level coursework or a Master’s degree in Data Science, Analytics, Bioinformatics, or a related quantitative field, particularly when combined with regulated laboratory experience
Benefits
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.