Job Description

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 approve 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. ~ Reporting Manager. ~ Quality Control. ~ Manufacturing Operations. ~ Manufacturing Engineering. ~ Manufacturing Science and Technology (MS&T). ~ Validation. ~ Site Engineering. ~ Digital Plant. Requirements : ~ Minimum 10 years' relevant work experience, with experience in a Quality Assurance role. ~ 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, TrackWise, 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. Katalyst HealthCares and Life Sciences

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