QC Data Senior Specialist

Job Description

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.

• 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
• Ensure compliance with data integrity and Good Documentation practices (GDP, ALCOA+) across all data workflows
• 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

• 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 Lab Vantage

• 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

• 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…