Job Description

We are seeking a Senior Manufacturing Associate to support the B7 restart of Epogen production by leading and executing Corrective and Preventative Actions (CAPAs) and Effectiveness Verifications (EVs). This role is ideal for candidates with a GMP background, deviation writing experience, and a continuous improvement mindset. You will collaborate with cross-functional teams and utilize project management skills to ensure compliance and operational excellence.
Responsibilities

• Own and execute CAPAs and EVs related to Epogen production, ensuring timely completion.
• Support continuous improvement initiatives to enhance efficiency, quality, and safety.
• Utilize project management tools to track, monitor, and report progress.
• Collaborate with stakeholders across quality, engineering, validation, and regulatory teams.
• Maintain compliance with cGMP, SOPs, and EHS policies.
• Contribute to risk management and safety culture improvements.

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

• Master’s degree + 2 years of experience OR
• Bachelor’s degree + 3 years of experience OR
• Associate’s degree + 5 years of experience OR
• High school diploma/GED + 10 years of experience
• Background in GMP manufacturing and deviation writing
• Experience with CAPA/EV ownership using Trackwise or similar quality systems
• Experience with Veeva Vault, Smartsheet, Trackwise, MS Project, Agile

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