QA lead technical operations

Responsibilities

• Provides Quality Assurance (QA) support to Devens Site and reporting Manager through quality review and approval of Investigations and Corrective Actions.
• Decision-making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
• Reviews and approves Quality, Quality Control, Validation and Automation documents
• Review and approve Standard Operating Procedures (SOPs)
• Review and approval of Validation documentation such as risk assessments, protocols, and test scripts and summary reports
• Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements
• Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation
• Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment
• Able to interpret complicated data and make sound decisions, independently
• This position will regularly interact with: Reporting Manager
• Sometimes will interact with the departments listed below: Quality Control, Manufacturing Operations, Manufacturing Engineering, Manufacturing Science and Technology (MS&T), Validation, Site Engineering, Digital Plant

Qualifications

• Knowledge of science is generally attained through studies resulting in a B.S; in Biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.
• Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product quality.
• Preferred Active member of ASQ or ISPE.
• Prior experience of 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.