Job Title: QC Lab Services Analyst Analytical Instruments & Lab Systems
Location: Wilson, NC (100% Onsite BioNC Facility)
Industry: Biotherapeutics / Pharmaceutical Manufacturing
Employment Type: Full-Time Contract
Shortlisting Deadline: Urgent / Immediate Screening (EOD 11/11)
Position Overview
We are seeking an experienced QC Lab Services Analyst to join the Quality Control team at a biotherapeutics manufacturing facility in Wilson, North Carolina. This on-site role is responsible for end-to-end laboratory equipment lifecycle management, analytical instrument qualification (IQ/OQ/PQ), and Computer System Validation (CSV) support. You will author protocols, write standard operating procedures (SOPs), and support the deployment of enterprise lab informatics systems (eLIMS, Empower, SDMS) to ensure cGMP compliance and audit readiness.
Key Responsibilities
Equipment Lifecycle & Qualification: Execute analytical equipment qualification protocols (IQ, OQ, PQ) for QC laboratory instruments, including HPLC, Spectrophotometry, Total Organic Carbon (TOC), Endotoxin (LAL) testing platforms, and Cell Culture systems.
Document Authorship & Technical Writing: Author and revise qualification protocols, test scripts, Standard Operating Procedures (SOPs), Work Instructions (WIs), and technical reports in adherence to Good Documentation Practices (GDP).
Lab Informatics & CSV Support: Provide CSV support for QC systems and participate in site deployment/integration of computerized systems such as eLIMS / iLabs, Empower CDS, SoftMax Pro, SDMS, and SAP.
Troubleshooting & Compliance: Investigate and resolve instrument out-of-specification (OOS) events, deviations, unexpected equipment failures, and system-level compliance issues.
Global Alignment: Collaborate with cross-functional manufacturing teams, site Quality Assurance, and global Centers of Excellence (CoE) for lab systems and equipment standards.
Required Qualifications
Education: Bachelor's degree in Chemistry, Biochemistry, Microbiology, Biology, or a related scientific discipline.
Experience: Minimum 2+ years of direct Quality Control (QC) laboratory experience within a cGMP pharmaceutical or biopharmaceutical manufacturing environment.
Equipment Qualification: Hands-on experience with equipment lifecycle management and IQ/OQ/PQ execution for QC analytical instrumentation (HPLC, Endotoxin, TOC, etc.).
Documentation: Proven experience authoring and revising SOPs, protocols, and technical reports under cGMP/FDA/EU regulations.
Systems: Direct working knowledge of laboratory software and systems (e.g., eLIMS, Empower, SoftMax Pro, SDMS).
Work Model: Ability to work 100% on-site in Wilson, NC.
Thanks
Sri Vardhan Chilakamukku