Analytical QA Auditor – Onsite (cGMP Focus)

Catalent; Greenville (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive PTO

8 paid holidays

Benefits from day one (medical, dental

Tuition reimbursement

Site activities and employee groups

Job summary

Catalent’s Greenville, North Carolina site is a major oral solid dose development and manufacturing campus focused on end-to-end solutions from formulation development through commercial manufacturing and packaging. The Quality Assurance Auditor – Analytical Review plays a key role in maintaining data integrity, ensuring GMP compliance, and promoting a culture of quality across the facility.

This onsite role requires 3+ years in pharma QA and a hands-on approach to review and approve labs,

Qualifications

• Bachelor’s degree in Life Sciences with 3+ years in pharma and 1+ year in QA
• Associate degree in Life Sciences with 2+ years in pharma and 2+ years in QA
• Demonstrated ability to perform detailed analytical review of GMP documentation, laboratory data, batch records, protocols, reports, and quality records
• Capacity to handle and manipulate objects using hands and arms

Responsibilities

• Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities
• Provide broad advocacy for the improvement of quality standards and quality culture across the organization
• Promote open communication and information sharing within Quality Assurance and throughout the facility
• Support the development of a climate of quality and safety within teams by identifying and monitoring standards
• Ensure compliance to all compendial, internal and client-specific requirements
• Review/approve laboratory reports and COAs
• Review/approve stability reports (LWRs) in SLIM
• Release of Raw Materials in ERP System
• Ensure all work is performed in accordance with SOPs and cGMPs
• Provide real time support for laboratories
• Other duties as assigned

Skills

Analytical review

Manual dexterity

Education

Bachelor’s degree in Life Sciences

Associate degree in Life Sciences

Job description

Catalent’s Greenville, North Carolina site is a major oral solid dose development and manufacturing campus focused on end-to-end solutions from formulation development through commercial manufacturing and packaging. The Quality Assurance Auditor – Analytical Review plays a key role in maintaining data integrity, ensuring GMP compliance, and promoting a culture of quality across the facility.

This onsite role requires 3+ years in pharma QA and a hands-on approach to review and approve labs,