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Senior Associate, Manufacturing
Job Description
In this role, you will work with a team responsible for supporting multiple Drug Product manufacturing operations, including formulation, sterile-isolator filling, aseptic filling, and lyophilization activities.
The team leads the efforts of maintaining the highest levels of safety, quality, compliance, and efficiency while balancing a dynamic production schedule. The Associate will work to support multiple internal customers and partners including Supply Chain, Quality Assurance, Process Development, and Engineering.
The Senior Associate Manufacturing will be specifically responsible for:
The team leads the efforts of maintaining the highest levels of safety, quality, compliance, and efficiency while balancing a dynamic production schedule. The Associate will work to support multiple internal customers and partners including Supply Chain, Quality Assurance, Process Development, and Engineering.
The Senior Associate Manufacturing will be specifically responsible for:
- Executing drug product filling activities
- Performing initial review of manufacturing batch records
- Maintaining a safe environment while adhering to compliance standards and by identifying additional preventative measures
- Crafting and/or revising standard procedures
- Leading continuous improvement initiatives, which may be multi-functional in nature
- Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
- Developing finite schedule for tasks including, unit operations
- Reviewing efficiency and identifying countermeasures for issues impacting cycle time alignment
- Elevating critical and impactful events to management
- Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
- Supporting the introduction of new products and technologies into the facility
- Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)
- Master’s degree OR
- Bachelor’s degree and 2 years of experience OR
- Associate’s degree and 4 years of experience OR
- High school diploma / GED and 6 years of experience
- GMP Knowledge
- Project Management experience
- Cross-Functional Team Building experience
- Prior pharma, Data visualization skills, Excel
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Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.