About the Role:

• This position supports a Quality Assurance program within the Plant QA organization, providing oversight of Drug Substance manufacturing areas.
• The role involves supporting Manufacturing and Facilities & Engineering areas/staff in executing processes, procedures, and quality systems. Responsibilities include floor presence, batch record review, SOP approval, work order approval, and quality approval of deviations and CAPA records.
• The Sr. Associate will also represent the Drug Substance Quality Assurance department in projects to achieve operational goals.

Responsibilities:

• Provide compliance oversight to Manufacturing and Facilities & Engineering areas/staff
• Review electronic batch records and approve SOPs, work orders, deviations, and CAPA records
• Evaluate compliance issues, provide recommendations, and ensure progress of quality records
• Represent the Drug Substance Quality Assurance department in projects Work in a team matrix environment

Education Qualification:

• Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field

Required Skills:

• Ability to perform GMP operations and make quality-based decisions
• Experience managing projects and meeting timelines
• Familiarity with evaluating documentation and operations according to company procedures
• Strong organizational skills and ability to manage multiple tasks
• Effective communication skills (written and verbal)
• Ability to work as a team player and independently
• Leadership attributes and drive improvement initiatives

Basic Qualifications:

• Master's degree, Bachelor's degree and 2 years of experience, Associate degree and 6 years of experience, High school diploma / GED and 8 years of experience

Pay rate - $35 - $37 per hour