QA lead technical operations

About the role

Provides Quality Assurance (QA) support to the Devens Site and reporting Manager through quality review and approval of Investigations and Corrective Actions. Makes decisions on non-conformance through a deep understanding of Quality Systems Regulatory expectations.

Responsibilities

• Review and approve Quality, Quality Control, Validation, and Automation documents.
• Review and approve Standard Operating Procedures (SOPs).
• Review and approve Validation documentation such as risk assessments, protocols, test scripts, and summary reports.
• Review and approve change proposals and associated deliverables, ensuring they meet external regulatory and internal WWQC guidelines and requirements.
• Coach across different departments on Investigations, CAPAs, general risk assessments, and Validation.
• Self-manage and prioritize work across multiple competing deliverables in a remote working environment.
• Interpret complicated data and make sound decisions independently.

This position will regularly interact with the reporting Manager and sometimes with the following departments:

• Quality Control
• Manufacturing Operations
• Manufacturing Engineering
• Manufacturing Science and Technology (MS&T)
• Validation
• Site Engineering
• Digital Plant

Requirements

• B.S. in Biological science, Engineering, Biochemistry, or related discipline, or its equivalent (preferred).
• Advanced level of relevant experience in a GMP, GCP, or GXP environment with at least 8 years focused on product quality.
• Preferred: Active member of ASQ or ISPE.
• Prior experience with QC equipment Qualification and some project management experience.
• Knowledge of biotech, bulk drug substance or finished product manufacturing, and medical device analytical testing is highly desirable.