GMP Process Specialist (2nd Shift) – Investigations & QA

U469 (FCRS = US469) AAA USA Inc.; Millburn (NJ); On-site; USD 70,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Paid time off

Job summary

Novartis in Millburn, NJ seeks an Associate Process Expert to support on‑the‑floor manufacturing and quality teams, resolving events and ensuring GMP compliance. The role leads investigations, CAPAs, and continuous improvement for Radioligand Therapy production on the 2nd shift (1:00 pm–11:00 pm, Wed–Sat).

The candidate will have a BS in Engineering/Pharmacy/Chemistry and at least 1 year on the shopfloor/QA/QC, with strong technical writing and cross‑functional collaboration skills.

Qualifications

• BS degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent scientific discipline.
• Minimum one year of shopfloor and/or Quality Assurance/Quality Control experience in a GMP facility.
• Understanding of pharmaceutical manufacturing processes and regulatory requirements.
• Strong technical writing skills for clear, inspection-ready documentation.

Responsibilities

• Provide on-the-floor support by triaging manufacturing events with Production and Quality teams.
• Open, author, and drive deviations and investigations to timely closure.
• Apply process knowledge and root cause analysis to resolve issues.
• Develop and implement corrective and preventive actions to prevent recurrence.
• Ensure investigations are complete, accurate, and inspection-ready for critical events.
• Execute or support experiments and manufacturing runs to support investigations.
• Partner cross-functionally to maintain compliant operations during and after deviations.

Skills

Cross-functional collaboration

Technical writing

Quality mindset

Problem solving

Education

BS in Engineering/Pharmacy/Chemistry

Job description

Novartis in Millburn, NJ seeks an Associate Process Expert to support on‑the‑floor manufacturing and quality teams, resolving events and ensuring GMP compliance. The role leads investigations, CAPAs, and continuous improvement for Radioligand Therapy production on the 2nd shift (1:00 pm–11:00 pm, Wed–Sat).

The candidate will have a BS in Engineering/Pharmacy/Chemistry and at least 1 year on the shopfloor/QA/QC, with strong technical writing and cross‑functional collaboration skills.