Senior QA Batch Release Lead for Aseptic Manufacturing

Lead Candidate; Indiana (PA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Paid time off

11 paid holidays

401(k) plan with company match

Health & wellness plans

FSA and HSA options

Onsite wellness facility

Employee engagement activities

Job summary

Lead Candidate is seeking a QA Batch Supervisor to support major QA programs and champion a Quality Mindset focused on efficiency, accuracy, and on-time delivery. You will identify and close operational and quality gaps while guiding the QA team in real-time batch record reviews.

The role requires a Bachelor’s degree in a related science, at least 5 years in aseptic processing in cleanrooms or isolator environments, and 3+ years in Quality Management Systems, deviation/CAPA, and change control.

Qualifications

• Bachelor’s degree in a related science.
• Minimum 5 years experience with aseptic processing in cleanroom or isolator environments.
• Minimum 3 years oversight of aseptic manufacturing and batch record review.
• Minimum 3 years experience in Quality Management Systems, Deviation/CAPA, Change Control.

Responsibilities

• Full lifecycle review and disposition of parenteral Batch Records (Formulation, Filling, Inspection, Packaging).
• Manage and oversee real time batch record floor review process.
• Provide Client access and support in Batch Records review/approval.
• Design and own QA Surveillance program for compliance in operations.
• Provide training to QA staff on surveillance and batch record requirements.

Education

Bachelor’s Degree in a related Science (Chemistry, Biology, Biochemistry, Microbiology)

Job description

Lead Candidate is seeking a QA Batch Supervisor to support major QA programs and champion a Quality Mindset focused on efficiency, accuracy, and on-time delivery. You will identify and close operational and quality gaps while guiding the QA team in real-time batch record reviews.

The role requires a Bachelor’s degree in a related science, at least 5 years in aseptic processing in cleanrooms or isolator environments, and 3+ years in Quality Management Systems, deviation/CAPA, and change control.