QA Batch Release Supervisor, IDAP

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

Working closely with the QA Manager, the QA Batch Supervisor will be instrumental in supporting major QA programs. They will also be key in championing and developing the organization’s Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. The QA Batch Release Supervisor will at all times provide support with identifying and closing Operational and Quality gaps.

WHAT?

• Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product.
• Manage and oversee the Batch Record “real time” floor review process.
• Provide Client access and support in the review and approval of Batch Records
• Design and own an ongoing QA Surveillance program for the assurance of compliance standards in operations areas.
• Provide training to all QA Associates and Specialists on surveillance oversight and on-the-floor Batch Record review requirements.

YOU!

• Bachelor’s Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
• 5 years minimum experience working with aseptic processing in cleanroom and/or isolator environments required.
• 3 years minimum experience of oversight of aseptic manufacturing and all production stage batch record review and disposition required.
• 3 years experience as performer or reviewer in Quality Management Systems, DMS, Deviation/CAPA, and Change Control required.

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.