Sr Associate QA - Thousand Oaks CA

Job Description

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 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 vital role you will be responsible to ensure that operations products are manufactured, tested, stored and distributed according to Good Manufacturing Practices (cGMP).

• Supports and audits and inspections preparation, planning, execution and response activities as well as facilitating completion of compliance and regulatory requests
• Provides QA oversight for IQA and ensures area readiness as the IQA compliance representative. Support IQA quality events, change controls and risk assessments.
• Supports ATO Management Review activities and metric control plan adherence
• May perform review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformances, CAPAs, Change Control records and validations. May also support execution of these tasks.
• Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
• Supports that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
• Supports Continual Improvement initiatives, programs and projects
• Alerts management of quality, compliance, supply and safety risks
• Represents the Quality Assurance during audits and inspections
• Completes required assigned training to permit execution of required tasks
• Responsible for complying with Good Manufacturing Practices and Good Documentation Practices

Masters

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

• High school/GED + 4 years of Quality Assurance work experience
• OR
• Associate’s + 2 years of Quality Assurance work experience
• OR
• Bachelor’s + 6 months of Quality Assurance work experience
• OR
• Master's

• Demonstrated knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulations.
• Experience with Quality Management System (QMS) processes
• Knowledge of quality metrics, Management Review processes, and continuous improvement methodologies.
• Experience supporting regulatory inspections, partner audits, and internal quality audits.
• Experience serving as a Quality Assurance representative within a manufacturing or quality organization.
• Excellent written and verbal communication skills, including the ability to present information to leadership and regulatory inspectors.

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual…