QC Specialist I

Role Summary

Quality Control Specialist I role leads critical quality control functions by performing and overseeing analytical testing, method validation, and external contractor coordination to ensure product integrity and regulatory compliance. They drive operational excellence through SOP development, 5S implementation, and daily lab maintenance that supports a well-organized and efficient QC environment. By managing investigations, qualifications, and documentation, the role significantly contributes to risk mitigation and continuous improvement across the organization and quality team.

Responsibilities

• Perform analytical testing of in-process samples, finished products, and stability studies in accordance with established protocols.
• Serve as validation lead and subject matter expert to support analytical method validation activities.
• Facilitate and oversee analytical testing performed by external contractors to ensure compliance and timely execution.
• Contribute to the implementation and ongoing maintenance of 5S principles within the QC laboratory to promote efficiency and organization.
• Create or update QC SOPs, protocols, and reports‚Äîincluding stability protocols, qualification documents, and summary reports.
• Perform daily laboratory tasks such as data review, laboratory maintenance, sample receipt and disposal, and chart recorder upkeep.
• Support laboratory investigations including OOT/OOS events, deviations, change controls, and CAPAs.
• Perform qualification of controls, reference materials, and critical reagents.

Qualifications

• Required: BS in Analytical Chemistry, Biochemistry or Biological Sciences or equivalent with 8+ years of industrial Quality Control experience.
• Required: Working knowledge of cGMP/ICH/ISO guidelines related to lab processes and GDP.
• Required: Working experience with enzymatic assays, ELISA, HPLC, LC/MS, GC, Karl Fischer, UV-Vis, qPCR, CE-SDS and electrophoresis.
• Required: Strong interpersonal and communication skills, both verbal and written, with a proven ability to work cross-functionally and present technical information clearly.
• Required: Experienced in authoring and reviewing validation protocols and technical reports to support method validation.
• Required: Meticulous approach to documentation, data integrity, and procedural accuracy.
• Required/Preferred: Ability to multitask and deliver high-quality results under tight timelines, while maintaining compliance and thorough documentation.

Skills

• Analytical chemistry and laboratory technique proficiency
• Method validation and technical report writing
• Quality systems and regulatory compliance in a lab environment
• Cross-functional collaboration and clear communication

Education

• BS in Analytical Chemistry, Biochemistry, Biological Sciences, or equivalent