QA Associate I
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 the GMP facilities at City of Hope (COH). Assists with distribution, tracking and archiving of clinical materials. Assists with audits, inspections, and staff in-service training as necessary.
Key Responsibilities include:
- 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.
- Writes reviews and processes the approval of Standard Operating Procedures.
- Responsible for clean room changeover activities such as performing Environmental monitoring, checking room logs, equipment calibration and trash.
- May be required to conduct external vendor audits and interact with internal COH departments (purchasing, safety etc) as directed. Communicate with external vendors as directed, to co-ordinate release test activities, and materials processing.
- Present project updates at project meetings and to management as requested. May be required to attend off-campus training or COH training seminars and participate in internal training.
- Wear pager, or other communication devices, and respond to emergency calls as needed.
Qualifications
Basic education, experience and skills required for consideration:
- Bachelor’s degree with background knowledge in biology (molecular or cellular), chemistry (inorganic, organic, or biochemistry), virology, engineering, or related field
- 0-2 years of experience supporting biologics manufacturing, small molecule synthesis and/or GMP facility operations
Preferred education experience and skills:
- Bachelor’s degree with background knowledge in biology (molecular or cellular), chemistry (inorganic, organic, or biochemistry), virology, engineering, or related field
- 2+ years of experience within GMP facility operations, biosafety, chemical safety, cGMP principles and practice and/or 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
Additional Information:
As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.