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Quality Assurance Lead

1 month ago

Fort Devens, United States Omni Inclusive Full time
Job Title: QA Lead Technical Operations, Projects

Omni Inclusive is seeking a highly skilled QA Lead Technical Operations, Projects to join our team.

Job Summary:

We are looking for a seasoned Quality Assurance professional to lead our Technical Operations, Projects team. The successful candidate will be responsible for providing quality assurance support to our Devens Site and reporting manager through quality review and approval of investigations and corrective actions.

Key Responsibilities:
  • Provide quality assurance support to Devens Site and reporting manager through quality review and approval of investigations and corrective actions.
  • Make decisions on non-conformance through a deep understanding of quality systems and regulatory expectations.
  • Review and approve quality, quality control, validation, and automation-related documents.
  • Review and approve standard operating procedures (SOPs).
  • Review and approve validation-related documentation, including risk assessments, protocols, and test scripts, and summary reports.
  • Review and approve change proposals and associated deliverables, ensuring they meet external regulatory and internal WWQC guidelines and requirements.
  • Coach across different departments on investigations, CAPAs, general risk assessments, and validation.
  • Self-manage and prioritize work across multiple competing deliverables in a remote working environment.
  • Independently interpret complicated data and make sound decisions.
Interactions:

This position will regularly interact with our reporting manager and sometimes with departments listed below:

  • Quality Control
  • Manufacturing Operations
  • Manufacturing Engineering
  • Manufacturing Science and Technology (MS&T)
  • Validation
  • Site Engineering
  • Digital Plant
Requirements:
  • Bachelor's degree in biological science, engineering, biochemistry, or a related discipline, or its equivalent.
  • Advanced level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product quality.
  • Active member of ASQ or ISPE.
  • Prior experience in QC equipment qualification and some project management experience.
  • Knowledge of biotech, bulk drug substance, or finished product manufacturing, medical device analytical testing.
  • Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
  • Knowledge of electronic systems, including SAP, LIMS, TrackWise, Veeva Vault, and electronic or paper-based batch records.
  • Excellent technical writing and oral communication skills.
  • Background in problem-solving.
  • Knowledge of data integrity principles.
  • Proven attention to detail.
  • Comfortable working in an FDA-regulated environment.