CASY-MSCCN Jobs

Job Description

A company based in San Antonio, TX is seeking a Regulatory Affairs Manager to enhance their team. The role involves overseeing the Quality Control team's activities, ensuring adherence to compliance at all product or sample testing stages, and conducting QC tests on in-process products, stability, and/or research samples, among other operational tasks.

The Quality & Compliance Manager will be instrumental in identifying areas for continuous process improvement, ensuring compliance with GMP processes, and maintaining documentation for quality control activities. The role demands strong technical abilities, analytical and mathematical skills, organizational and time management skills, and excellent verbal and written communication skills. Attention to detail is crucial.

Furthermore, this role includes the responsibility of staff training and development. The Quality & Compliance Manager will need to exercise sound judgement and make timely decisions that ensure the safety, reliability, potency, and purity of products/results.

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

* Bachelors Degree in Applied Science

* Must have Multi product facility experience & regulatory body supporting FDA / EU inspections / ISO inspections audit experience

* Extensive experience with Regulatory Affairs/Compliance

* Experience with being client facing and holding external relationships

* 5+ years in QA/biological manufacturing experience

* 3+ years of management/supervisor experience * QA at the source or floor support experience lot release

* Master's degree

* Aseptic Biologics , clean room experience

* Any experience root cause analysis,

* Master Control 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.