Catalent
Overview
Join to apply for the
Quality Assurance Specialist
role at
Catalent . The Position Catalent’s Greenville, NC facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. 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. Role 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 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. Candidate qualifications 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 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 exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Legal and EEO information 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 sending an email, and confirming your request for an accommodation 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. Security notice Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. Job details Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Biotechnology, Research and Pharmaceutical Manufacturing
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Join to apply for the
Quality Assurance Specialist
role at
Catalent . The Position Catalent’s Greenville, NC facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. 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. Role 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 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. Candidate qualifications 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 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 exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Legal and EEO information 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 sending an email, and confirming your request for an accommodation 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. Security notice Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. Job details Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Biotechnology, Research and Pharmaceutical Manufacturing
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