Quality Assurance II

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Job description

Quality Assurance Associate II - Duarte, CA

Position Summary:
Responsible for assisting the QA Manager and Senior QA Associate in achieving compliance with all Federal and State laws and regulations and other accrediting agency requirements in the collection, processing, preparation, and distribution of biopharmaceutical products manufactured in GMP facilities. Assists with distribution, tracking and archiving of clinical materials. Assists with audits, inspections, and staff in-service training as necessary.

Essential Functions:

• Performs quality assurance activities for equipment, building, processes and products to ensure compliance with Good Manufacturing Practices (GMP).
• Reviews production output batch records and assures that the proper procedures and processes have been used in the production of the products prior to approval by QA Manager.
• Compile master production and control batch records and archive documents.
• Assists QA Facilities manager for the continuous operation of the facility's mechanical systems, monitoring systems and equipment.
• Responsible for co-coordinating preventative maintenance and maintaining cGMP compliance of all building systems and major process equipment (e.g. autoclaves, dishwashers, depyrogenation oven), as directed by QA Facilities Manager.
• Conduct internal cGMP and safety training to manufacturing staff, may provide training to new staff and will be OQS lead on manufacturing projects.
• Initiate OOS/CAPA investigations, propose resolutions and process related forms.
• Writes reviews and processes the approval of Standard Operating Procedures and quality policies.
• Responsible for clean room changeover activities such as performing Environmental monitoring, checking room logs, equipment calibration and trash.
• Present project updates at project meetings and to management as requested. Participate in audits and interact with collaborators. May be required to attend off-campus training or company training seminars.
• May be required to conduct external vendor audits. Interact with internal departments (purchasing, safety etc) as directed. Communicate with external vendors as directed, to co-ordinate release test activities, and materials processing.
• Wear pager, or other communication devices, and respond to emergency calls as needed.
• Follows established company and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan.
• Practices a high level of integrity and honesty in maintaining confidentiality.
• Performs other related duties as assigned or requested.

Position Qualifications:

• BS or BA in biology, chemistry, virology or engineering (MS degree preferred)
• 3+ years of experience in Quality Assurance supporting biologics manufacturing, small molecule synthesis, GMP facility operations
• GMP facility operations experience -Biosafety courses, chemical safety, cGMP principles and practice, equipment maintenance.
• Certification from ASQ or other professional organization /recognized institutions related to quality (i.e. quality auditor, quality manager, facility operations). Biotech sponsored seminars, workshops on regulations, policies, and procedures impacting cGMP/GLP activities related to biologics manufacturing.
• Excellent written and oral communication skills
• Knowledgeable about State and Federal regulatory requirements

For Immediate Consideration, Apply Today! For more information contact Maji at /

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