Associates QA - Batch Compliance

Responsibilities

• Review GMP manufacturing documentation for the release of active ingredients
• Control intermediate and final stage documentation for GMP compliance and adherence to internal regulations
• Discuss discrepancies with production personnel and coordinate necessary corrective actions
• Act as "QA Person in Plant" through regular presence in production to perform spot checks on in-progress GMP documentation
• Verify customer eligibility for active ingredient procurement and review shipping documentation for GMP products
• Implement Good Distribution Practice (GDP) guidelines regarding the provision, handling, and distribution of GMP products

Requirements

• Apprenticeship as Chemielaborant, CTA, or Chemisch-Pharmazeutische Technologe (or comparable qualification)
• At least 2 years of professional experience in the chemical or pharmaceutical industry, preferably in a GMP environment
• Proven experience in creating, reviewing, and enforcing corrective actions for documentation
• Proficiency in Microsoft Office and experience with electronic Quality Management Systems (QMS)
• Fluency in German (written and spoken) and good command of English
• Independent, responsible, and detail-oriented working style with a strong understanding of quality assurance

Preferred Qualifications

• Experience or interest in electronic batch documentation systems (MES)
• Knowledge of SAP

Benefits

• Dynamic and growing work environment with internal development opportunities
• Flexible working hours
• Various internal and external training and professional development programs
• 60% employer contribution to the pension fund
• Access to the Swibeco benefits platform for various discounts
• On-site staff restaurant offering fresh and healthy food
• Access to free sports activities on the Bachem Campus

About the Company

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of expertise, Bachem provides products for research, clinical development, and commercial use to pharmaceutical and biotech companies worldwide.