Biomanufacturing Compliance Associate Lead I

Catalent Pharma Solutions; Kentucky; In loco; USD 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical benefits

Tuition Reimbursement

Paid holidays

Descrizione del lavoro

Catalent’s Madison, Wisconsin site is seeking an Associate Lead I - Biomanufacturing, Compliance to support cGMP manufacturing operations and ensure adherence to SOPs, regulatory, and client requirements. The role emphasizes maintaining quality and driving continuous improvement, with a focus on deviations, audits, CAPAs, and on‑the‑floor support.

The position requires strong cGMP knowledge, SOP authoring skills, and collaboration across teams in a fast-paced manufacturing environment, with a

Competenze

• High School Diploma or GED with at least 4 years of related experience.
• Associate’s degree in a STEM field with 1 year of related experience or a Bachelor’s degree in a STEM field with no experience required.
• Proficiency in Microsoft Office and ability to learn quality/scientific systems (TrackWise, ComplianceWire, JD Edwards, Unicorn).
• Applies cGMP principles to ensure compliant, high‑quality execution of procedures.
• Foundational knowledge of manufacturing and laboratory operations.

Mansioni

• Facilitate Rapid Response Team deviations and document root cause.
• Review logbooks to ensure data meets cGMP expectations and track investigations.
• Support internal audits and closure of findings.
• Assist with training needs and educational requirements for staff and equipment.
• Assist in authoring SOPs for new processes or when gaps exist.

Conoscenze

cgmp knowledge

root-cause analysis

sop authoring

training & coaching

Formazione

High School or GED + 4y exp

AS degree in STEM

Bachelors in STEM

Strumenti

TrackWise

ComplianceWire

JD Edwards

Unicorn

Descrizione del lavoro

Catalent’s Madison, Wisconsin site is seeking an Associate Lead I - Biomanufacturing, Compliance to support cGMP manufacturing operations and ensure adherence to SOPs, regulatory, and client requirements. The role emphasizes maintaining quality and driving continuous improvement, with a focus on deviations, audits, CAPAs, and on‑the‑floor support.

The position requires strong cGMP knowledge, SOP authoring skills, and collaboration across teams in a fast-paced manufacturing environment, with a