QA Lead Technical Operations, Projects

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 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 This position will regularly interact with: Reporting Manager Sometimes will interact with departments listed below: Quality Control Manufacturing Operations Manufacturing Engineering Manufacturing Science and Technology (MS&T) Validation Site Engineering Digital Plant Education, 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 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.

Contractor must be able to come onsite Monday through Friday - 1st shift #J-18808-Ljbffr TechDigital Group