MCS Manufacturing Sr. Associate

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.

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.
• Managing and owning Corrective and Preventative Actions (CAPAs) and Effectiveness Verifications (EVs) in support of the B7.
• Supporting continuous improvement.
• Supporting Risk management.
• Supporting Safety Culture.

Skills:

• 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.

Requirements

Qualifications

• Master’s degree and two years of Manufacturing or Operations experience OR
• Bachelor’s degree and three years of Manufacturing or Operations experience OR
• Associate’s degree and five years of Manufacturing or Operations experience OR
• High school diploma / GED and 10 years of Manufacturing or Operations experience
• Experience with CAPA and EV ownership and execution, preferably using Trackwise or similar quality system.

Preferred Qualifications:

• Degree in engineering, science, or related field, or equivalent combination of education and experience.