QA Lead Technical Operations

4 days ago

Devens, United States Katalyst Healthcares and Life Sciences Full time
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.
  • This position will regularly interact with the Reporting Manager.
  • Quality Control.
  • Manufacturing Operations.
  • Manufacturing Engineering.
  • Manufacturing Science and Technology (MS&T).
  • Validation.
  • Site Engineering.
  • Digital Plant.
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.

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