JT648 - MCS SR. 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 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.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.