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Quality Assurance (QA) Associate II - Duarte, CA

Kelly Services

Duarte, CA
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Job Details

Job Title Quality Assurance (QA) Associate II - Duarte, CA

Jobid US15TPJI_BH1414802

Location: Duarte, CA, 91009, USA

Description **Quality Assurance (QA) Associate II**

**Essential Duties and Responsibilities:**

+ Performs quality assurance activities for equipment, building, processes and products to ensure compliance with Good Manufacturing Practices (GMP).
+ Reviews and compiles master production batch and control batch records
+ QA project lead for manufacturing campaigns
+ Conducts and reviews routine facility monitoring tasks.
+ Writes, Review and process controlled documents.
+ Provide validation/preventative maintenance support for critical equipment and write associated protocols.
+ Maintains and creates QS tracking databases.
+ Participate in the efforts in achieving compliance with all Federal and State accrediting agency requirements.
+ Performs quality assurance activities for equipment, building, processes and products to ensure compliance with Good Manufacturing Practices (GMP). Assist QS in establishing and maintaining Quality Systems as they pertain to facility operation.
+ Writes, reviews and processes the approval of Standard Operating Procedures.
+ Assists in internal inspections and audits (manufacturing, QC, safety) to ensure compliance with Federal Drug Administration (FDA) regulations and company and QS policy requirements.
+ 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. Assists QC in the review of product COA. Compile master production and control batch records.
+ Initiate OOS/CAPA investigations, propose resolutions and process related forms.
+ When necessary, assist with receiving, acceptance, handling, and storing of raw materials.
+ Assist in QS streamlining activities.
+ Responsible 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 Manager.
+ Serve as department safety representative as directed by the QA Manger.
+ Cooperates with other performance improvement and compliance activities in the institution.
+ Represents Quality Assurance function through interaction with Principal Investigators as directed by QA Manager.
+ Maintains knowledge of current regulatory/accreditation requirements, changes and issues, inspection citations, quality assurance training, management, and organizational development activities.
+ Maintains and creates databases to track and trend monitoring data including environmental monitoring, equipment maintenance, excursions in facility operations. Analyze trends and generate reports/updates from these databases.
+ Internal Contacts: Communicate with all manufacturing, QC and QS staff as it relates to document review & approval, master production and control batch record compilation, release test coordination, materials release/storage and facility/equipment maintenance issues. Conduct internal audits, follow-ups and write report for QAM or Senior QA Associate. Conduct internal cGMP and safety training. Train new QS personnel. Communicate with limited COH departments for project related issues. Present project updates at project meetings and to management as requested. Present routine updates at QS team meetings.
+ May be required to archive documents.
+ Performs other related duties as assigned or requested.
**Job Requirements:**

+ Bachelor of Science (BS) degree with 3 - 5 years of experience, OR
+ Master of Science (MS) with 0 – 4 years of experience.
+ Preferred Courses/Training: Basic Biology (Molecular and Cellular) Chemistry (Inorganic, Organic and Biochemistry).
+ Autonomous and self directed.
+ Excellent writing skills required, including grammar and spelling. Able to correctly use technical terms and abbreviations
+ Excellent organizational skills.
+ GMP facility operations.
+ Biosafety courses, chemical safety, cGMP principles and practice, equipment maintenance.
**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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