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JT648 - MCS SR. MANUFACTURING ASSOCIATE
JT648 - MCS SR. MANUFACTURING ASSOCIATEQuality Consulting Group, LLC • Thousand Oaks, CA, US
JT648 - MCS SR. MANUFACTURING ASSOCIATE

JT648 - MCS SR. MANUFACTURING ASSOCIATE

Quality Consulting Group, LLC • Thousand Oaks, CA, US
3 days ago
Job type
  • Full-time
Job description

Senior Manufacturing Associate

Quality Consulting Group, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated, and enthusiastic individual to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities

  • Lead and execute CAPAs and EVs related to Biopharmaceutical manufacturing ensuring timely completion and documentation.
  • Identify and implement continuous improvement opportunities to enhance process efficiency, quality, and safety.
  • Gather and ensure quality CAPA Applicability responses.
  • Use project management tools and methodologies to plan, monitor, and report on CAPAs, EVs and project progress and outcomes.
  • Responsible for owning, executing and completing multiple CAPAs and EVs across multiple buildings.
  • Communicate effectively with internal and external partners, such as quality, engineering, validation, regulatory, and suppliers.
  • Adhere to all applicable policies, procedures, and standards, such as cGMP, SOPs, and EHS.
  • Ensure the right actions have been suggested, implemented and tested in a way that is audit robust, while ensuring eliminating repeat errors.

Qualifications

  • Bachelor's degree in Engineering, Science, or related field
  • 3 years of Manufacturing or Operations experience
  • Basic Manufacturing knowledge
  • Project Management skills
  • CAPA experience would be a nice to have, not required.
  • Experience with CAPA and EV ownership and execution, preferably using Veeva Systems or similar quality system.
  • Strong analytical, problem-solving, and decision-making skills
  • Ability to work independently and collaboratively, with a high level of initiative and accountability
  • Excellent verbal and written communication skills, with attention to detail and accuracy
  • Experience with project management tools and techniques, such as MS Project, Agile, Smartsheet, or Lean Six Sigma. (preferred)
  • Shift : 1st shift (Mon – Fri)
  • Hybrid but must be local to Thousand Oaks. Will be fully onsite in the beginning with opportunity to WFH some days after the first few months.
  • Location : Thousand Oaks, CA

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    Manufacturing Associate • Thousand Oaks, CA, US

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