Sr Associate QA - Thousand Oaks CA

Military Spouse Corporate Career Network•Thousand Oaks, CA

9d•Onsite

About The Position

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

Requirements

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

Nice To Haves

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.

Responsibilities

Ensure that operations products are manufactured, tested, stored and distributed according to Good Manufacturing Practices (cGMP).
Support and audit and inspection preparation, planning, execution and response activities as well as facilitating completion of compliance and regulatory requests.
Provide QA oversight for IQA and ensure area readiness as the IQA compliance representative.
Support IQA quality events, change controls and risk assessments.
Support 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.
Collaborate cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures.
Support that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
Support Continual Improvement initiatives, programs and projects.
Alert management of quality, compliance, supply and safety risks.
Represent the Quality Assurance during audits and inspections.
Complete required assigned training to permit execution of required tasks.
Responsible for complying with Good Manufacturing Practices and Good Documentation Practices.