Job Description
Insight Global is seeking a remote Sr. Quality Consultant for a role working with a small combination product company on the east coast.
In this role you will work with the quality department to move engineering efforts of both drug and device quality, combination products and injectables.
Must be open to working east coast hours
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.
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Required Skills & Experience
Sterilization experience, specifically in ETO (Ethylene Oxide) process
Familiarization with ISO 11135 and ISO 11067
Notified Body experience specifically auditing ISO and EU MDR
QMSR gap assessment and execute
Experience in both drug and device quality, combination products, preferably injectables
DHF audits for various phases of devices
Project remediation experience
Nice to Have Skills & Experience
Injectables experience
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching.
Employees in this role are also entitled to paid sick leave and / or other paid time off as provided by applicable law.
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