Quality Control Document Administrator

Arcera Life Sciences

The Quality Control Document Controller is responsible for ensuring effective control of all QC documentation and sample management processes, in alignment with GLP, GMP, and data integrity principles, supporting laboratory compliance, resources coordination, and ensures smooth execution of QC operations from material receipt to reporting.

Job Responsible:

• Manage QC documents (SOPs, specifications, STPs, release reports, logbooks, training records) in compliance with ALCOA++ principles.
• Ensure timely drafting, revision, approval, and archival of SOPs, specifications, standard test procedures, and reports.
• Maintain document storage, retrieval, and archival systems (manual and electronic such as SAP, Dot Compliance, etc.).
• Monitor document version control and ensure accessibility to authorized personnel only.
• Oversee receipt, registration, and distribution of QC samples as per lot management and sample receiving procedures.
• Ensure proper handling, storage, and tracking of samples (raw materials, packaging, intermediates, finished products, and stability).
• Performing sampling activities for raw materials and water system samples in compliance with GLP and SOPs.
• Maintain sample retention and disposal records as per regulatory and company requirements.
• Monitor and reinforce adherence to GLP practices within the QC laboratory.
• Support internal audits, inspections, and compliance activities by ensuring availability and accuracy of records.
• Report and escalate any observed deviations, non-compliance, or data integrity concerns to QC Manager.
• Coordinate usage and availability of sampling and testing resources (sampling tools, logbooks, controlled forms, etc.).
• Support QC Manager in managing laboratory schedules, prioritizing sample workflows, and aligning resources for timely completion.
• Ensure laboratory personnel training records are maintained, up-to-date, and available for audits.
• Ensure all activities are performed in compliance with EHS policy and PPE requirements.
• Maintain strict confidentiality of QC data, documents, and product information.
• Participate in improvement initiatives for QC operations and documentation processes.
• Provide inputs for system enhancements (SAP, LIMS, documentation tools) to streamline QC efficiency.
• Perform any other responsibilities assigned by the QC Manager to support department needs.

Qualifications & Skills:

• Knowledge of data integrity (ALCOA+), GLP, and regulatory requirements.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities.
• Familiarity with SAP, LIMS, or other digital quality/document management systems is an advantage.