Catalent, Inc
Quality Assurance Specialist I
San Diego, CA
Sponsorship not specifiedDetected 6 days ago
Product ManagementExcelERPCustomer SupportClinical TrialsGMPPublic SpeakingMicrosoft Office
About the role
- Author, review, update, and approve quality documentation, procedures, reports, and regulatory records.
- Work Schedule: Monday-Friday, core hours 8am-4:30pm
- Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent's San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic.
Responsibilities
- Serve as a Quality Systems subject matter expert (SME), utilizing JDE to support material management, batch records, product inspection, label release, and quality processes.
- Lead and support investigations, deviations, complaints, change controls, engineering studies, equipment qualifications, and corrective actions.
- Partner with cross-functional teams and clients to resolve quality issues, provide guidance, present quality metrics, and drive effective rapid-response activities.
- Train, mentor, and develop Quality Specialists while supporting onboarding, process improvements, and continuous quality enhancement initiatives.
- Demonstrate a One Catalent approach by collaborating across site and global quality functions to maintain compliance, operational excellence, and customer satisfaction.
Requirements
- Frequent standing, walking, and sitting required.
- Occasional kneeling and reaching required.
Nice to have
- High School Diploma or GED required.
- High School Diploma with 7+ years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
- BS with 5+ years of experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
- MS with 3+ years of experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
- Minimum of 3 years of customer service experience.
- Bachelors or Master's degree in a scientific discipline preferred.
- JD Edwards or comparable ERP systems preferred.
Skills
- 100% on-site (San Diego)
Compensation
- The anticipated salary range for this role in California is $72,000 to $74,000 annually.
- The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
- Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
- Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
- Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment.
- Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
- Defined career path and annual performance review and feedback process.
Benefits
- Competitive salary with bonus potential.
- Generous 401K match and Paid Time Off accrual.
- Medical, dental and vision benefits effective day one of employment.
- 152 hours of PTO + 10 paid holidays.
- Tuition Reimbursement - Let us help you finish your degree or earn a new one!
Equal opportunity
- Several Employee Resource Groups focusing on Diversity and Inclusion.
- Equal Opportunity Employer, including disability and veterans.
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