Catalent Pharma Solutions
Quality Assurance Specialist
Catalent Pharma Solutions, Greenville, North Carolina, United States, 27834
Quality Assurance Specialist
Catalent’s Greenville, North Carolina facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. The facility has had substantial recent investments and features fit-for-scale capacity with potent handling capabilities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The Quality Assurance Specialist position requires the ability to perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned. The QA Specialist will advocate for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent supports product development, launch, and full life-cycle supply, with experience across development sciences, delivery technologies, and multi-modality manufacturing. Catalent supports the acceleration of development programs and the launch of many products each year, with global sites and large-scale capabilities.
The Role
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 and supporting laboratory staff as assigned.
Review quality documentation including laboratory reports, CoAs, methods, specifications, method validation protocols and method validation reports.
Remain proficient and knowledgeable within the respective field of operation, 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.
The Candidate
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.
Why You Should Join Catalent
Competitive medical benefits and 401K
152 hours of PTO + 8 Paid Holidays
Dynamic, fast-paced work environment
Opportunity to work on Continuous Improvement Processes
Catalent offers rewarding opportunities to further your career. Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an international company where employees work with pharma, biopharma and consumer health companies to advance new medicines from development to market. Catalent produces billions of doses per year and aims to make a difference.
Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by email and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted to Catalent by a third party agency or search firm without a valid signed agreement will be the property of Catalent. No fee will be paid for unsolicited referrals.
Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide payments or highly sensitive personal information during the offer process, and never via email or social media. If you receive such requests, do not respond and forward to spam@catalent.com for investigation.
California Job Seekers can find our California Job Applicant Notice here.
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The Quality Assurance Specialist position requires the ability to perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned. The QA Specialist will advocate for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent supports product development, launch, and full life-cycle supply, with experience across development sciences, delivery technologies, and multi-modality manufacturing. Catalent supports the acceleration of development programs and the launch of many products each year, with global sites and large-scale capabilities.
The Role
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 and supporting laboratory staff as assigned.
Review quality documentation including laboratory reports, CoAs, methods, specifications, method validation protocols and method validation reports.
Remain proficient and knowledgeable within the respective field of operation, 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.
The Candidate
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.
Why You Should Join Catalent
Competitive medical benefits and 401K
152 hours of PTO + 8 Paid Holidays
Dynamic, fast-paced work environment
Opportunity to work on Continuous Improvement Processes
Catalent offers rewarding opportunities to further your career. Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an international company where employees work with pharma, biopharma and consumer health companies to advance new medicines from development to market. Catalent produces billions of doses per year and aims to make a difference.
Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by email and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted to Catalent by a third party agency or search firm without a valid signed agreement will be the property of Catalent. No fee will be paid for unsolicited referrals.
Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide payments or highly sensitive personal information during the offer process, and never via email or social media. If you receive such requests, do not respond and forward to spam@catalent.com for investigation.
California Job Seekers can find our California Job Applicant Notice here.
#J-18808-Ljbffr