MCS Manufacturing Sr. Associate

Immediate opportunity for a Sr. Associate Manufacturing to support the re-start of Epogen production with one of the world's leading biotechnnology companies located in Thousand Oaks, CA. The ideal candidate will have a continuous improvement mindset, strong communication skills, and a willingness to learn. This role involves owning and managing Corrective and Preventative Actions (CAPAs) and Effectiveness Verifications (EVs), as well as supporting risk management, safety culture, and operational excellence initiatives. This is an exciting opportunity for a motivated professional looking to contribute to a high-impact manufacturing initiative in a dynamic, cross-functional environment. Apply today!

Schedule/Shift: 1st shift, Mon.-Fri., 8am-5pm

Position type: 1 yr. contract (through Feb. 2026); extension possible

Job Summary: As a Senior Associate Manufacturing, you will be responsible for managing and owning Corrective and Preventative Actions (CAPAs) and Effectiveness Verifications (EVs) in support of the B7 restart of Epogen production. You will also participate in continuous improvement initiatives and utilize project management skills to achieve operational excellence. You will work in a cross-functional team and collaborate with various stakeholders to ensure quality and compliance.

Essential Duties and Responsibilities:

• Lead and execute CAPAs and EVs related to Epogen production, ensuring timely completion and documentation.
• Identify and implement continuous improvement opportunities to enhance process efficiency, quality, and safety.
• Use project management tools and methodologies to plan, monitor, and report on 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.

Qualifications:

• Master’s degree (MA / MS) and one (1) year of Manufacturing / Operations experience, OR
• Bachelor’s degree (BA / BS) and three (3) years of Manufacturing / Operations experience, OR Associate’s degree (AA / AS) and five (5) years of Manufacturing or Operations experience, OR High school diploma / GED and 10 years of Manufacturing or Operations experience.
• Degree in engineering, science, or related field.
• Two (2) years of GMP experience with a background in writing deviations and executing quality processes.
• Prefer some experience with CAPA and EV ownership and execution, preferably using Trackwise 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.
• Not required but ideal, experience with project management tools and techniques, such as MS Project, Agile, Smartsheet, Veeva