QA Lead Technical Operations

Responsibilities: • Provides Quality Assurance (QA) support to Devens Site and reporting Manger 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 related documents. • Review and approves Standard Operating Procedures (SOPs). • Review and approval of Validation related 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. Requirements: • Knowledge of science 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, medical device analytical testing is highly desirable. • Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5. • Knowledge of electronic systems including any of the following: SAP, LIMS, Track Wise, Veeva Vault and electronic or paper-based batch records desirable. • Excellent Technical writing and oral communication skills are required. • Background in problem solving. • Knowledge of Data integrity principles. • Proven attention to details. • Comfortable working in an FDA regulated environment. Top Skills: • Quality Control Equipment experience preferred. • Technical Writer. • Investigations/Deviation experience preferred. Apply tot his job