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Catalent · 1 day ago

Quality Assurance Auditor

Greenville, NC

Full-time

Onsite

Mid Level

3+ years exp

Catalent is a global leader in drug development and delivery, and they are seeking a Quality Assurance Auditor to provide key quality support and leadership for commercial and pre-commercial processes. The role involves ensuring compliance with quality standards, promoting a culture of quality, and supporting manufacturing and packaging operations.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

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)

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

Qualification

Quality AssuranceCGMP complianceBatch record reviewPharmaceutical industry experienceCommunication skills

Required

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

152 hours of PTO + 8 paid holidays

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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2022 (1)