Quality Assurance Specialist II

Responsibilities

• Perform production room, dispensary, and shipment clearance verifications
• Revise standard operating procedures (SOPs) and other GMP documents such as stability protocols and raw material specifications
• Manage GMP documentation workflows and ensure accurate scanning and archiving of BPRs and chromatograms
• Coordinate, review, and approve quality events
• Provide support for regulatory, customer, and internal audits
• Drive continuous improvements and represent QA in process improvement project teams
• Implement and maintain the Quality Management System
• Train new hires and provide cGMP guidance to other departments

Requirements

• Bachelor's Degree in organic chemistry or a related science field
• 3-5 years of experience in Quality Assurance or Quality Control
• 3-5 years of experience in internal auditing and working with regulatory agencies
• 3-5 years of experience working in ISO 7 and ISO 8 controlled environments
• Strong knowledge of cGMP, FDA regulations, GxP, and Quality Management Systems
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Ability to review technical scans (BPRs, chromatograms) with high accuracy
• Strong organizational and multitasking skills in a fast-paced, deadline-driven environment

Preferred Qualifications

• Master's Degree in organic chemistry or a related field
• ASQ Certified Quality Process Analyst (CQPA)
• Certified Quality Auditor (CQA)
• Certified Quality Engineer (CQE)

Benefits

• Competitive base annual salary
• Annual performance bonus
• Comprehensive Medical, Dental, and Vision coverage
• 401(k) plan with employer contribution
• Paid vacation, personal, and sick days

About the Company

Bachem AG is a leading manufacturer of peptides and oligonucleotides. We take responsibility for future generations through careful resource handling and environmental stewardship, holding an EcoVadis Gold Medal status for our ecological performance.