QA Lead Technical Operations, Projects

QA Lead Technical OperationsProjects Onsite, Devens location Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)Job Description/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 expectationsReviews and approves Quality, Quality Control, Validation and Automation related documentsReview and approves Standard Operating Procedures (SOPs)Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reportsReview and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirementsAbility to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and ValidationAbility to self-manage and prioritize work across multiple competing deliverables, in a remote working environmentAble to interpret complicated data and make sound decisions, IndependentlyThis position will regularly interact with:Reporting ManagerSometimes will interact with departments listed below:Quality ControlManufacturing OperationsManufacturing EngineeringManufacturing Science and Technology (MS&T)ValidationSite EngineeringDigital PlantEducation, Experience, and Qualifications: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 experienceKnowledge 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, TrackWise, Veeva Vault and electronic or paper based batch records desirable.Excellent Technical writing and oral communication skills are required.Background in problem solvingKnowledge of Data integrity principlesProven attention to detailsComfortable working in an FDA regulated environment.Contractor must be able to come onsite Monday through Friday - 1st shift