QC Technician (Gosselies)

Inteliphage; Belgique; Sur place; EUR 36 000 - 48 000; Plein temps

Résumé du poste

Inteliphage in Gosselies, Belgium, is seeking a QC Technician to perform analytical and microbiological testing to support release of phage products. You'll contribute to GMP-compliant lab set-up and qualification, reporting to Technical Operations Manager and collaborating with the Lab team.

On-site work 4-5 days per week is required for operational needs, and candidates must be based in Belgium with valid work authorization.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2–3 years of microbiology, analytical or QC laboratory experience.
• Experience in a GMP-regulated environment is strongly preferred.
• Good understanding of GMP quality systems (deviations, CAPA, risk assessment).
• Experience with equipment qualification and analytical method transfer is an asset.
• Fluency in French and working level of English is required.

Responsabilités

• Perform routine QC analyses according to SOPs and testing schedules.
• Conduct microbiological testing related to bacteriophage products, including titration.
• Prepare media, reagents and samples using aseptic techniques.
• Execute sampling and QC testing of raw materials and packaging components.
• Document observations, results and deviations in GMP-compliant records.
• Assist in investigations of deviations and CAPAs.
• Support preparation for audits and inspections.

Connaissances

Aseptic techniques

Data integrity

Communication

Teamwork

Formation

Bachelor's degree in Life Sciences or related field

Outils

Laboratory equipment knowledge

Description du poste

As a QC Technician, you play a key role in performing the analytical and microbiologicaltesting required to support the release of Inteliphage bacteriophage products. You contribute to the set-up, qualification and GMP compliance of the GosseliesQC laboratory.

You will report to the Technical Operations Managerand will be working closely with the Lab team.

PLEASE NOTE: This position is based in Gosselies, Belgium, and requires on-site presence 4 to 5 days per week due to the operational nature of the role; candidates must already be based in Belgium and have valid authorization to work in Belgium.

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.
• 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 data and compilation of the results.

Laboratory Maintenance& Organization

• Comply with the applicable safety, biosafety (BL2) and GMP rules at all times, including the gowning requirements for the laboratory and for classified areas.
• Ensure appropriate handling, storage and traceability of reagents, reference materials, standards and samples.
• Ensure laboratory equipment and work areas are used and maintained according to approved procedures.
• Maintain the QC laboratory in a clean, organized and GMP-compliant condition.
• Manage microbiological waste and laboratory waste according to applicable safety and environmental procedures.
• Perform routine cleaning, sanitization and laboratory housekeeping activities.
• Monitor laboratory consumables and manage inventory needs.
• Follow up equipment calibration, qualification status and preventive maintenance in line with the laboratory metrology and calibration plan, and ensure that no equipment is used outside its calibration or qualification validity.

What you bring to the table

• Bachelor’s degree in Life Sciences, Microbiology, Biotechnology, Bioengineering, or a related field.
• 2-3 years of experience in a microbiology, analytical or QC laboratory is required.
• Experience in a GMP-regulated laboratory environment is strongly preferred.
• Knowledge of GMP quality systems (deviations, change control, CAPA, risk assessment) and of the handling of OOS/OOT results.
• Experience with equipment qualification and with analytical method transfer, verification or validation is an asset.
• Good understanding of aseptic techniques and microbiological laboratory practices.
• Familiarity with laboratory equipment and routine laboratory maintenance.
• Accurate, methodical and detail-oriented working style.
• Strong commitment to data integrity, documentation and quality.
• Ability to follow established procedures while working independently on routine activities.
• Good organizational skills and ability to manage several testing activities according to priorities.
• Clear and concise communication skills.
• Ability to work effectively within a multidisciplinary team.
• Willingness to work in a BL2 laboratory and to comply with BL2 and GMP gowning requirements.
• Fluency in French and a good working level of English (reading and written) are required.
• MUST have a valid work permit for Belgium.
• Work to be performed on site

What you’ll love about working here

Inspiring Mission

Join a high-potential biotech fighting antimicrobial resistance with cutting-edge science.

Strategic Impact

Lead global efforts to bring next-gen solutions to market and transform the fight against antibiotic resistance.

Develop your skills and grow professionally in a dynamic environment.

Empowered Leadership

Drive change within a passionate team that supports and challenges each other to excel.

Attractive Compensation

Enjoy a competitive package aligned with your role and experience.

Work-Life Flexibility

Benefit from hybrid work and flexible hours tailored to your lifestyle.

Be part of a team that values collaboration, creativity, and mission-first thinking.

Enjoy team breakfasts, lunches, afterworks, and memorable team-building moments.