Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Let's do this. Let's change the world. In this dynamic role you will collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility. Responsibilities of the role include:

• Executing drug product filling and formulation 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)

Additional Qualifications/Responsibilities
Basic Qualifications:

• High school diploma / GED and 2 years of Manufacturing experience OR Asociate's degree and 6 months of Manufacturing experience OR Bachelor's degree

Preferred Qualifications:

• B.S. in a life science or related field
• 2 years of work experience in a GMP environment
• Ability to perform computer operations, such as ability to navigate in MS Office and Excel
• Ability to operate specialized equipment and computers as appropriate to the individual area
• Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Ability to evaluate documentation/data according to company and regulatory guidelines
• Ability to interact with inspectors (internal and external)
• Technical writing capabilities
• Ability to organize work, handle multiple priorities and meet deadlines
• Demonstrated written and oral communication skills
• Presentation capabilities
• Detail oriented as well as flexible and adaptable to changing priorities and requirements.
  67,083.00 USD - 84,094.00 USD