Quality Control Sample Manager (Contract)

What You’ll Do:

• Oversee end‑to‑end QC sample lifecycle: receipt, login, labeling, inventory creation, storage, distribution, shipment, and disposition.
• Maintain accurate sample inventories for in‑process materials, raw materials, retains, stability samples, reference standards, and controls.
• Support and address sample‑management-related audit observations; implement corrective and preventive actions (CAPAs).
• Perform weekly lab audits using standardized checklists for all QC laboratories; ensure issues are captured, escalated, and closed.
• Conduct audit trail review for QC instruments and systems, ensuring timely and compliant documentation .
• Review and maintain QC laboratory logbooks for accuracy, completeness, and compliance with GDP requirements.
• Attend all Facilities & Controls (FAC) meetings; escalate QC‑related issues, equipment risks, and sample handling concerns.
• Investigate and document equipment Out‑of‑Tolerance (OOT) events and coordinate required follow-up actions.
• Perform cell culture activities and maintain aseptic technique to support cell‑based analytical assays as needed.
• Perform Rees alarm risk assessments for controlled‑temperature units (CTUs) and establish clear criteria for when deviations must be initiated (e.g., defined threshold durations for -80°C units).
• Conduct quarterly reviews of Rees alarms to identify trends, risks, and required corrective actions.
• Coordinate calibrations (Cals), preventative maintenance (PMs), and equipment maintenance (EMs) across QC laboratories; ensure timely completion and documentation.
• Update, revise, and create equipment-related SOPs, work instructions, alarm response procedures, and lifecycle documents.
• Support method qualification/validation, material qualification, and equipment qualification (IQ/OQ/PQ) activities as needed.
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• Author and revise SOPs, forms, and documentation related to sample management, lab operations, alarm response, and equipment handling.
• Participate in internal audits, external inspections, and quality system assessments by providing documentation and subject‑matter expertise.
• Collaborate cross‑functionally with QC, QA, Manufacturing, Supply Chain, and Facilities to improve processes, reduce risks, and strengthen compliance.
• Contribute to continuous improvement initiatives to streamline laboratory workflows and enhance data integrity.
 

About You:

• Bachelor’s degree in a scientific discipline (Biology, Chemistry, Biochemistry, or related field).
• Minimum 4–6 years of experience in a GMP analytical laboratory, QC environment, or sample management role.
• Strong understanding of cGMP requirements and regulatory expectations for biotechnology and pharmaceutical QC operations.
• Experience with LIMS, electronic inventory systems, or sample tracking databases.
• Familiarity with stability programs, cold‑chain management, and chain‑of‑custody workflows.
• Strong organizational skills with exceptional attention to detail and documentation accuracy.
• Excellent communication skills and ability to work cross‑functionally.
• Demonstrated problem‑solving ability and adaptability to shifting priorities.
• Proficiency with MS Office and laboratory equipment software.