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Catalent · 3 days ago

Quality Assurance Specialist

Greenville, NC

Full-time

Onsite

Mid Level

4+ years exp

Catalent, Inc. is a leading global contract development and manufacturing organization dedicated to improving health through innovative solutions. The Quality Assurance Specialist will perform routine and non-routine Quality Assurance tasks, ensuring compliance with quality standards and supporting the development of a quality culture within the organization.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

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 assistance to laboratories with appropriate quality oversight

Escalate unplanned events and issues, providing immediate notification to QA Management, supporting and providing guidance to laboratory staff as assigned

Review Quality documentation including but not limited to review of laboratory reports, CoAs, methods, specifications, method validation protocols and method validation reports

Remain proficient and knowledgeable within respective field of operation in accordance with job responsibility and function, able to troubleshoot process, system, material and technique-related issues

Act as QA representative on project teams, providing Quality guidance and support

All other duties as assigned

Qualification

Quality AssurancePharmaceutical IndustryBatch Record ReviewSOP ComplianceCommunication SkillsTeam CollaborationProblem Solving

Required

Bachelor's degree with 4 years of professional experience in the pharmaceutical industry, preferably with 2 years in a Quality role or

Associate degree with 5 years of professional experience in the pharmaceutical industry, preferably with 3 years in a Quality role

At least 1 year of batch record review and on the floor quality assurance manufacturing support

Position requires the capacity to handle and manipulate objects using hands and arms

Benefits

Competitive medical benefits and 401K

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

Represents job field similar to this job

Trends of Total Sponsorships

2022 (1)