NCBiotech
Quality Assurance Auditor
Provide quality support and leadership to development, operations, and laboratory personnel for commercial and pre-commercial processes and projects.
Position Summary This position is 100% on-site at the Greenville site.
The Role
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).
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.
All other duties as assigned.
The Candidate
Bachelor’s degree with three years of professional experience required in the pharmaceutical industry, preferably with one year in a Quality role.
Associate degree with four years of professional experience required in the pharmaceutical industry, preferably with two years in a Quality role.
At least one year of batch record review and on the floor quality assurance manufacturing support required.
Position requires the capacity to handle and manipulate objects using hands and arms.
Benefits
Spearhead exciting and innovative projects.
Fast‑paced, dynamic environment.
High visibility to members at all levels of the organization.
152 hours of PTO + 8 paid holidays.
EEO Statement Catalent is an Equal Opportunity Employer, including disability and veterans.
Contact Visit Catalent Careers to explore career opportunities.
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Position Summary This position is 100% on-site at the Greenville site.
The Role
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).
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.
All other duties as assigned.
The Candidate
Bachelor’s degree with three years of professional experience required in the pharmaceutical industry, preferably with one year in a Quality role.
Associate degree with four years of professional experience required in the pharmaceutical industry, preferably with two years in a Quality role.
At least one year of batch record review and on the floor quality assurance manufacturing support required.
Position requires the capacity to handle and manipulate objects using hands and arms.
Benefits
Spearhead exciting and innovative projects.
Fast‑paced, dynamic environment.
High visibility to members at all levels of the organization.
152 hours of PTO + 8 paid holidays.
EEO Statement Catalent is an Equal Opportunity Employer, including disability and veterans.
Contact Visit Catalent Careers to explore career opportunities.
#J-18808-Ljbffr