QC Data Senior Specialist

The Quality Control Data Senior Specialist supports Quality Control, Operations, and cross-functional stakeholders by owning the organization, analysis, and usability of QC and customer-facing laboratory data. This role partners closely with the lab Technical Supervisor, Lab Operations, R&D, Supply Chain, Commercial, and IT teams to ensure laboratory data are accurate, traceable, analyzable, and audit-ready.

The scope includes QC data aggregation across systems, laboratory analytics, LIMS utilization, and collaboration on data storage, pipelines, and dashboards supporting operational, regulatory, and customer needs.

This position is responsible for collecting, standardizing, trending, and reporting quality control data generated from laboratory testing, environmental monitoring, equipment qualification, and material inspections. The Senior Specialist ensures QC data are consistent, compliant, and usable for regulatory review, CAP inspections, and internal decision-making. This role does not hold any CAP signatory or supervisory responsibility.

• Ability to read and interpret 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)
• Ability to maintain and adjust scripts used for laboratory/manufacturing data ingestion, analysis, and SPC chart generation
• 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 strongly preferred
• Comfortable with managing change in a dynamic lab environment with shifting priorities, new technologies, and growth demands
• Preferred: Previous experience working with LIMS platforms such as Sapio or LabVantage

Work Environment:

• Ability to work in environmental conditions typical in office and clinical laboratory environments
• Time split between laboratory areas and office/meeting spaces
• Requires use of personal protective equipment (PPE) such as lab coats, gloves, and eye protection when in lab areas, * 5+ years of experience in a regulated industry, preferably in the clinical laboratory, biotechnology, or pharmaceutical spaces
• 2+ years of experience in a QC, analytics, or process engineering role
• Hands-on experience with laboratory/manufacturing data systems, reporting tools, or analytics pipelines used to support quality or process monitoring

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.

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. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team., For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $105,000.00 - $115,000.00 annually. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.