Sr. Manufacturing Associate

Senior Associate, Manufacturing (CAPA and Effectiveness Verification)

Location : Ventura County, CA. Candidates must be local to the area.

Schedule : Monday to Friday, day shift.

Work Arrangement : Hybrid. Fully onsite for the first few months, with the opportunity to work from home some days after that.

Job Summary

A global biopharmaceutical manufacturing organization is seeking a Senior Associate, Manufacturing to own and manage Corrective and Preventative Actions (CAPAs) and Effectiveness Verifications (EVs) in support of clinical supply manufacturing. This person will also participate in continuous improvement initiatives and apply project management skills to drive operational excellence. The role works within a cross-functional team and partners with a variety of stakeholders to ensure quality and compliance.

Job 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 overall project progress and outcomes.
• 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.

Minimum Qualifications (one Of The Following)

• Master’s degree and 2 years of Manufacturing or Operations experience
• Bachelor’s degree and 3 years of Manufacturing or Operations experience
• Associate’s degree and 5 years of Manufacturing or Operations experience
• High school diploma or GED and 10 years of Manufacturing or Operations experience

Preferred Qualifications

• Degree in engineering, science, or a related field, or an equivalent combination of education and experience.
• Experience with CAPA and EV ownership and execution, preferably using an electronic quality management system such as Veeva or similar.
• 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 (not required, but ideal).