Associate Manufacturing

Role Summary

Associate Manufacturing role supporting drug product filling, batch record review, SOP development, and quality processes at the Thousand Oaks facility. You will collaborate with multiple functions (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering) to understand manufacturing operations and planning activities and support new products and technologies.

Responsibilities

• Completing drug product filling activities, respectively
• Performing initial review of manufacturing batch records
• Maintaining a safe and compliant culture by identifying preventative measures
• Creating and/or revising standard operating procedures
• Leading continuous improvement initiatives, which may be cross-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, but not limited to unit operations
• Monitoring productivity and identifying countermeasures for issues impacting cycle time adherence
• Elevating critical and impactful events to management
• Applying 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)

Qualifications

• Required: High school diploma / GED and 2 years of Manufacturing experience OR Associate’s degree and 6 months of Manufacturing experience OR Bachelor’s degree
• Preferred: 2 years of work experience in a GMP environment
• Preferred: Ability to perform computer operations, such as ability to navigate in MS Office and Excel
• Preferred: Ability to operate specialized equipment and computers as appropriate to the individual area
• Preferred: Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Preferred: Ability to evaluate documentation/data according to company and regulatory guidelines
• Preferred: Ability to interact with inspectors (internal and external)
• Preferred: Technical writing capabilities
• Preferred: Ability to organize work, handle multiple priorities and meet deadlines
• Preferred: Demonstrated written and oral communication skills
• Preferred: Presentation capabilities
• Preferred: Detail oriented as well as flexible and adaptable to changing priorities and requirements

Skills

• Technical writing capabilities
• Demonstrated written and oral communication skills
• Presentation capabilities
• Detail oriented; flexible and adaptable to changing priorities and requirements

Education

• High school diploma / GED
• Associate’s degree
• Bachelor’s degree
• BS in life science or related field (Preferred)