mRNA QA Documentation & QC Compliance Specialist

Work Schedule

Environmental Conditions

Job Description

Job Description

The mRNA Business Unit is seeking a QA Documentation & QC Compliance Specialist to join our Quality team.

In this role you will contribute to ensuring product quality and regulatory compliance within our pharmaceutical manufacturing operations. By supporting documentation and QC compliance activities you will play a key role in enabling our mission of making the world healthier cleaner and safer.

Your work will directly support the production of life-changing medicines while maintaining the highest standards of quality and compliance.

Key Responsibilities

• Support QA oversight of documentation processes within a GMP-regulated environment

• Review and manage quality documentation (e.g. SOPs specifications protocols reports)

• Ensure QC activities and documentation comply with GMP requirements and internal procedures

• Support laboratory investigations deviations and associated records

• Maintain and manage records within quality systems (e.g. TrackWise Documentum)

• Contribute to inspection readiness and support regulatory inspections and customer audits

• Collaborate cross-functionally with QC Manufacturing and other departments to ensure compliance and continuous improvement
  

Qualifications & Experience

• 12 years of experience in Quality Assurance or within a GMP-regulated pharmaceutical environment

• Bachelors degree in Chemistry Pharmacy Biology Biotechnology or a related scientific field

• Solid knowledge of GMP regulations FDA guidelines and quality systems

• Experience in QA documentation management (procedures specifications records)

• Good understanding of QC laboratory environments and analytical processes

• Experience with quality management systems (e.g. TrackWise Documentum)

• Knowledge of root cause analysis and quality improvement tools

• Experience with laboratory investigations is considered a plus

• Ability to interpret and apply technical procedures and specifications
  

Knowledge Skills & Competencies

• Strong written and verbal communication skills

• Excellent attention to detail and analytical problem-solving abilities

• Ability to manage multiple priorities in a fast-paced environment

• Strong organizational and project management skills

• Effective interpersonal skills and ability to collaborate cross-functionally

• Experience supporting regulatory inspections and audits

• Proficiency in Microsoft Office applications