Associate Manufacturing (Swing Shift 2pm-11pm)

Role Summary

Associate Manufacturing (Swing Shift 2pm-11pm) at the Thousand Oaks site. You will collaborate with multiple functions (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering) to develop a deep understanding of manufacturing operations and planning activities. This role includes performing drug product manual visual inspections, reviewing manufacturing batch records, maintaining a safe and compliant culture, creating and revising standard operating procedures, leading cross-functional continuous improvement initiatives, performing data analysis of critical process parameters, developing task schedules, monitoring productivity, and managing quality records such as non-conformances and CAPAs.

Responsibilities

• Performing drug product manual visual inspection activities
• 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: Bachelor’s degree OR Associate’s degree and 6 months of GMP/GDP experience OR High school diploma / GED and 2 years of GMP/GDP experience
• Preferred: B.S. in a life science or related field
• 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

• Ability to perform computer operations and navigate MS Office and Excel
• Operate specialized equipment and computers as appropriate to the individual area
• Adhere to regulatory requirements, written procedures and safety guidelines
• Evaluate documentation/data according to company and regulatory guidelines
• Interact with inspectors (internal and external)
• Technical writing capabilities
• Organize work, handle multiple priorities and meet deadlines
• Demonstrated written and oral communication skills
• Presentation capabilities
• Detail oriented, flexible and adaptable to changing priorities and requirements