Laboratory Operation Assistant (m/f/d)

Discovery Life Sciences, Inc.; Kassel; Vor Ort; EUR 42.000 - 56.000; Vollzeit

Zusammenfassung

Discovery Life Sciences is seeking a Laboratory Documentation Specialist in Kassel, Germany, to manage qualification, validation, and lifecycle documentation for laboratory equipment in a GxP/ISO 15189 environment.

The role coordinates equipment qualification and maintenance, maintains SOPs and training records, manages inventory, and supports audits and CAPA activities. Fluency in English and strong organizational skills are essential.

Qualifikationen

• English: very good written and spoken communication.
• Strong organizational skills with a structured and detail-oriented working style.
• Ability to manage multiple tasks and priorities simultaneously.

Aufgaben

• Prepare, maintain, and update qualification, validation, and lifecycle documentation for laboratory equipment.
• Coordinate equipment qualification, calibration, servicing, maintenance, and repair activities with internal stakeholders and external service providers.
• Maintain laboratory documentation, including SOPs, logbooks, forms, equipment files, and controlled documents.
• Maintain the laboratory training matrix and support training documentation.
• Manage laboratory inventory, including reagents, consumables, and laboratory supplies.
• Prepare purchase requests and coordinate ordering of laboratory supplies.
• Prepare and support internal and external audits, inspections, and monitoring visits, including follow-up documentation.

Kenntnisse

English proficiency

Organizational skills

Multitasking ability

MS Office proficiency

Ausbildung

Bachelor’s degree in Biology, Chemistry, Life Sciences

Equivalent education or experience

Tools

LIMS

Jobbeschreibung

Discovery Life Sciences is a leading provider of highly characterized human biospecimens and cellular starting materials to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions. We support new therapeutic approaches with reliable biomarker data in clinical trials and help physicians to achieve the goal of making the best treatment available to patients.

Position Qualifications (Education, Skills, Experience):

• Certifies Medical Laboratory Technician (MTA/MTL), Biological Technical Assistant (BTA), Chemical Technical Assistant (CTA), or equivalent qualification or
• Bachelor’s degree (B.Sc.) in Biology, Chemistry, Life Sciences, or a related scientific discipline is an advantage
• Equivalent education, training, or relevant professional experiences will also be consideres.
• Experience working in a regulated laboratory environment (GCP, GLP, GMP, or ISO 15189) is an advantage.
• Familiarity with laboratory documentation, quality management systems, and equipment qualification is an advantage.
• Experience with laboratory techniques such as histology, cell biology, molecular pathology, and/or protein biochemistry is beneficial but not required.
• Experience with Laboratory Information Management Systems (LIMS) is an advantage.
• Strong organizational skills with a structured and detail-oriented working style.
• Ability to manage multiple tasks and priorities simultaneously.
• Very good written and spoken English.
• Proficient in Microsoft Office and general computer applications.

Key Responsibilities:

• Prepare, maintain, and update qualification, validation, and lifecycle documentation for laboratory equipment.
• Coordinate equipment qualification, calibration, servicing, maintenance, and repair activities with internal stakeholders and external service providers.
• Maintain laboratory documentation, including SOPs, logbooks, forms, equipment files, and controlled documents.
• Maintain the laboratory training matrix and support training documentation.
• Manage laboratory inventory, including reagents, consumables, and laboratory supplies.
• Maintain reagent inventories, lot number tracking, and expiry date monitoring.
• Prepare purchase requests and coordinate ordering of laboratory supplies.
• Prepare and support internal and external audits, inspections, and monitoring visits, including follow-up documentation.
• Support CAPA implementation and documentation resulting from audits, inspections, and deviations.
• Prepare substrate solutions, buffer solutions, and other laboratory reagents according to established procedures.
• Coordinate proficiency testing programs with external accreditation and certification bodies (e.g., CAP, NordiQC), including documentation and submission of results.
• Coordinate and monitor internal proficiency testing programs, including documentation.
• Support document archiving and records management according to GCP and internal quality requirements.
• Assist with general laboratory organization and continuous improvement of laboratory operational processes.

Compensation and Benefits:

Discovery Life Sciences is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.