QA Auditor: Manufacturing (Onsite, Day-One Benefits)

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

Benefits offered by this job

Medical, dental, and vision benefits (

Job summary

Catalent Pharma Solutions in Greenville, NC is seeking a Quality Assurance Auditor - Manufacturing to perform routine and non-routine QA tasks supporting internal clients and commercial processes. The role is 100% onsite, Monday–Friday, 8:00am–5:00pm, with a focus on data integrity and GMP compliance.

If you bring a Bachelor’s or Associate degree with relevant pharma experience and a track record in batch records review and on-the-floor QA, you will help sustain a culture of quality and safety

Qualifications

• Bachelor's degree with 3 years of professional experience in the pharmaceutical industry with 1 year in a direct QA role.
• Associate degree with 4 years of professional experience in the pharmaceutical industry with 2 years in a direct QA role.

Responsibilities

• Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities.
• Provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization.
• Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout the facility.
• Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards.
• Ensure compliance to all compendial, internal and client-specific requirements (i.e. SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable).
• Perform in-process QA checks.
• Assure release of raw materials and components prior to manufacturing/packaging.
• Provide real-time support activities for manufacturing and packaging operations.
• Review batch records.
• Ensure all work is performed and documented in accordance with approved standard operating procedures, in compliance with cGMPs.
• Other duties as assigned.

Skills

Quality Assurance

cGMP compliance

Documentation control

Data integrity

Education

Bachelor's degree in pharmaceutical sciences

Associate degree in related field

Job description

Catalent Pharma Solutions in Greenville, NC is seeking a Quality Assurance Auditor - Manufacturing to perform routine and non-routine QA tasks supporting internal clients and commercial processes. The role is 100% onsite, Monday–Friday, 8:00am–5:00pm, with a focus on data integrity and GMP compliance.

If you bring a Bachelor’s or Associate degree with relevant pharma experience and a track record in batch records review and on-the-floor QA, you will help sustain a culture of quality and safety