QC Technician

What your days could look like

QC Testing & Laboratory Activities

• Perform routine QC analyses according to approved SOPs, analytical methods and testing schedules.
• Perform microbiological and analytical testing related to bacteriophage products, including phage titration and other applicable assays.
• Prepare and handle microbiological samples, including bacteriophages and bacterial indicator organisms, using appropriate aseptic techniques.
• Prepare media, buffers, reagents and solutions required for QC testing.
• Operate laboratory equipment and instruments according to approved procedures and training.
• Perform testing of samples supporting release, stability and process monitoring activities.
• Support sample preparation and shipment to external Contract Testing Laboratories when testing is outsourced.
• Perform sampling and QC testing of raw materials, excipients and packaging components, and generate the analytical data supporting batch disposition and release.
• Incubate, read, identify and trend environmental monitoring samples taken by the Production team.
• Execute the stability programme: set-down of stability samples, testing at the defined pull points and management of retention samples.
• Receive, qualify, sub-culture and manage QC reference standards, bacterial strains and phage banks, ensuring full traceability of passages and storage conditions.
• Handle Out-of-Specification (OOS) and Out-of-Trend (OOT) results according to the applicable procedure: immediate escalation, laboratory investigation, re-testing and documentation of the conclusions.
• Immediately report atypical observations, deviations, unexpected results or equipment issues to the Technical Operations Manager.

Data, Documentation & GMP Compliance

• Accurately record analytical activities, observations and results in laboratory records and applicable electronic systems.
• Ensure analytical data are recorded contemporaneously and in accordance with ALCOA+ and Data Integrity principles.
• Participate in the writing and revision of SOPs, work instructions (WKI), analytical methods, forms and logbooks applicable to the QC laboratory.
• Complete analytical worksheets, logbooks, forms and other QC documentation accurately and within the required timelines.
• Review own analytical records for completeness, accuracy and traceability before submission for review.
• Perform second-person verification (four-eyes) of critical analytical steps, calculations and data entries when assigned.
• Maintain complete traceability of samples, reagents, standards and analytical activities.
• Follow applicable GMP, laboratory safety, biosafety and company procedures at all times, and apply the safety rules in force on site in all circumstances.
• Support the preparation and execution of laboratory activities related to audits and inspections.
• Initiate and document deviations, change controls and CAPAs related to QC activities, and participate in the associated risk assessments.
• Contribute to the follow-up of QC performance indicators (KPI), such as on-time testing, OOS/OOT rate and closure of laboratory deviations.
• Maintain the required training level for all assigned activities and contribute to the training and onboarding of new laboratory team members.
• Ensure the archiving and retention of QC records and raw data in accordance with the applicable data retention policy.

Collaboration & Continuous Improvement

• Work under the supervision of Technical Operations Manager to ensure QC testing is aligned with manufacturing activities and testing schedules.
• Communicate analytical results, laboratory issues and testing progress clearly and in a timely manner.
• Participate in investigations related to laboratory deviations, atypical results and analytical issues, and propose corrective and preventive actions.
• Contribute to troubleshooting of routine analytical or laboratory issues.
• Participate in the implementation and improvement of laboratory procedures and routines.
• Contribute to the development of an efficient, reliable and GMP-compliant QC laboratory at Gosselies.
• Act as back-up for other QC technicians to ensure continuity of testing during absences.

Site Set-up, Qualification & Validation

• Contribute to the set-up of the Gosselies QC laboratory: definition of laboratory requirements, reception, installation and start-up of analytical equipment.
• Participate in the qualification of QC equipment and laboratory facilities (IQ/OQ/PQ) and in their periodic requalification.
• Support analytical method transfer, verification and validation, including execution of the protocols, generation of raw da