QA Documentation Specialist m/f/d

Aristo Group; Luzern; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Aristo Group in Luzern is seeking a QA Documentation Specialist to support clinical biologics manufacturing by ensuring ALCOA+ compliant documentation and GMP readiness.

You will be embedded in Manufacturing Operations, partnering with shop floor teams, SMEs, and Quality to promote right‑first‑time execution and robust record lifecycle management for both paper records and EBR.

Qualifikationen

• Bachelor’s degree or equivalent in life sciences or related field.
• GMP manufacturing experience, preferably biologics.
• Hands-on batch record review or shop-floor support.
• Solid understanding of GDP principles.
• Experience with paper and/or electronic batch records (EBR).

Aufgaben

• Review executed batch records for accuracy and completeness.
• Create, revise and maintain batch record templates and SOPs.
• Support deviation investigations and document corrections.
• Control archiving, retention, and traceability of documents.
• Collaborate across Process Operations, Quality, and Tech Transfer.

Kenntnisse

Batch record review

GMP documentation

Cross-functional collaboration

GDP principles

Records management

Ausbildung

Bachelor’s degree in life sciences or related field

Tools

PAS-X

Syncade

Jobbeschreibung

The QA Documentation Specialist supports clinical biologics manufacturing by performing operational review of executed batch records and ensuring documentation supports ALCOA+ standards and GMP expectations.

The role is part of the Operational Excellence team within Manufacturing Operations and focuses on right‑first‑time execution, documentation robustness, and efficient record lifecycle management across paper‑based batch records and Electronic Batch Records (EBR).

This position works closely with shop floor teams, manufacturing SMEs, and Quality while remaining fully embedded in Manufacturing.

Key Responsibilities

Executed Batch Record Review

• Perform operational review of executed batch records for clinical biologics manufacturing, including:
• Upstream Processing (USP)
• Downstream Processing (DSP)
• Weighing & Dispense (W&D)
• Review paper-based batch records and EBR for alcoa+, data integrity, and GDP compliance
• Review executed PI sheets in COMET (SAP) to ensure material tracking compliance and identify gaps or inconsistencies in planning BOMs
• Identify documentation gaps, errors, or inconsistencies and coordinate timely resolution with manufacturing teams
• Support right‑first‑time execution and continuous improvement of documentation practices

Documentation Creation & Lifecycle Support

• Support the creation, maintenance, and update of batch record templates (paper and EBR) in collaboration with Process Operations, Tech Transfer, Process MES, and Quality
• Contribute to the creation, revision, and periodic review of manufacturing SOPs, work instructions, and forms
• Support implementation of documentation updates into manufacturing operations

Deviation & Correction Support

• Support documentation‑related deviations, corrections, and clarification activities
• Provide input and supporting documentation for deviation investigations related to manufacturing records

Document Handling & Archiving

• Issue and control floor copies of approved batch records and manufacturing documents
• Support GMP‑compliant archiving, retention, and controlled destruction of manufacturing documents in accordance with procedures
• Ensure traceability and version control of manufacturing documentation throughout the document lifecycle

Required Qualifications

• Bachelor’s degree or equivalent experience in life sciences, biotechnology, engineering, or a related field
• Experience working in a GMP manufacturing environment, preferably biologics
• Hands‑on experience with batch record review, manufacturing documentation, or shop‑floor support
• Solid understanding of GDP principles
• Experience with paper batch records and/or Electronic Batch Records (EBR)

Preferred Qualifications

• Experience in clinical manufacturing environments
• Familiarity with USP / DSP operations
• Experience with W&D and solution/media preparation documentation
• Exposure to MES / EBR systems (e.g. PAS‑X, Syncade)
• Strong attention to detail and structured working style
• Ability to work cross‑functionally with Process Operations, Tech Transfer, Process MES, and Quality
• Strong written documentation and technical writing skills
• Proactive mindset with focus on process robustness and continuous improvement
• Strong German and English language skills required for clear manufacturing communication and preparation, review, and maintenance of GMP‑relevant documentation