Quality Excellence Associate II
Insight Global
Job Description
One of our large pharmaceutical clients is looking to hire a Quality Excellence Associate to join their growing team. This individual will be leading Continuous Improvement site initiatives that improve safety, improve overall quality of execution, increase process efficiencies, and reduce cycle time and cost. Main responsibilities will include, but are not limited to:
- Pull and analyze data from quality groups to prepare analyses and presentations, streamline processes, and develop insights for team meetings.
- Format all reporting/data sets for meeting agenda, prepare presentations, and upload CRB Minutes in EDMS.
- Combine weekly data to analyze and send out for review. Format all reporting for presentation and upload QSMR report into Truvault.
- Investigate Trend report to track deliverables, format report and upload in EDMS.
- Support development of Quality Risk Management Framework.
- Support Quality Systems Tasks e.g., Site Master File maintenance, Gap Assessments, Quality Agreements
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .
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Skills and Requirements
-A minimum of a bachelors degree is required, preferably in Engineering, Science or equivalent technical discipline.
-5 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required
-Ability to maintain written records of work performed in paper-based and computerized quality systems is required.
-Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is required
-Knowledge and exposure to nonformences, CAPAs,
-Experience with Data Analytics -Experience within Quality Risk Management
-Project management experience null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
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