Quality Assurance Specialist II

About the role

Performs pre and post execution batch record review. Authoring/Updating documents related to Material Management Quality Control, Material Management Quality Assurance, Batch Records, Compliance, and Validation Systems. Participates in Investigations and deviation writing. Support client communications. Reviewing /approving change controls and change actions Adhere to GMP standards routinely with limited errors and limited guidance Other duties as assigned. The Candidate: High School Diploma or GED required. Bachelors or Master's degree in a scientific discipline preferred. High School Diploma with 10+ years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge and experience. BS with 7+ years of experience in a GMP environment, or comparable pharmaceutical knowledge and experience. MS with 5+ years of experience in a GMP environment, or comparable pharmaceutical knowledge and experience. JD Edwards or comparable ERP systems preferred. Proficient knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP's, Excel Formulas, building presentations in PowerPoint, etc.). Physical Requirements: Frequent standing, walking, and sitting required. Position occasionally requires lifting, pushing, and pulling of up to 35 lbs. Occasional kneeling and reaching required. Pay: The anticipated salary range for this role in California is $85,000 to $89,000 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. Why you should join Catalent: Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. 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. Several Employee Resource Groups focusing on Diversity and Inclusion. 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. Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. Tuition Reimbursement - Let us help you finish your degree or earn a new one! WellHub program to promote overall physical wellness. Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. 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