Sample and Lab Coordinator (SLC)
SGS Consulting
Job Responsibilities:
- Receive, record, store, dispose, and ship biological samples in compliance with GxP and internal procedures for Biomarker/CDx, pharmacokinetic (PK), and ADA samples.
- Perform QC checks on shipment manifests and resolve discrepancies with stakeholders.
- Ensure laboratory areas are maintained, and equipment is qualified, calibrated, and in good working order.
- Manage laboratory consumables and inventory, maintaining accurate records.
- Contribute to continuous improvement initiatives and process optimization.
- Coordinate with clinical teams, research and development, bioanalytical/PK experts, and external partners for sample management.
- Oversee Central Lab activities and support audits and inspections.
- Maintain LIMS and central lab portals, assist with protocol reviews, and develop biospecimen documentation.
Skills:
- Proficiency in biospecimen management, laboratory coordination, and GxP compliance.
- Strong communication and interpersonal skills for cross-functional collaboration.
- Expertise in LIMS (e.g., Watson LIMS) and bioanalytical methodologies.
- Advanced proficiency in Excel and digital solutions for data analysis.
- Organizational and project management skills.
Education/Experience:
- Bachelor’s degree in life sciences (Biology, Pharmacy, Veterinary, or related discipline).
- Minimum 2 years of experience in biospecimen management and/or laboratory coordination in a regulated environment (GLP, GCLP, ICH-GCP).
- Proficiency in bioanalytical methodologies and regulatory requirements for drug development.
- Excellent communication skills, proficiency in English (written and spoken).
- Master’s degree in life sciences (Biology, Pharmacy, Veterinary, or related discipline).
- Experience with translational medicine operations and clinical trials.
- Knowledge of CDISC standards and controlled terminology.
- Experience in preclinical study support and laboratory operations management.
Vacancy posted a month ago
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