Quality Systems Specialist
Company Description
QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!
Job Description
Quality Systems Specialist with experience in the pharmaceutical industry with:
- Knowledge in Quality Systems and SOP.
- Strong knowledge of relevant GMP, FDA, 21 CFR Part 11 and Data Integrity Regulations (Risk Assessment, Data Mapping, etc), EU regulations and the ability to interpret and apply them for intended use.
- Proficient knowledge of computer systems (Microsoft Office etc.) with data collection software (database) and applications like Infinity and SAP.
- Solid ability for analyzing data, detecting deviations, inconsistencies and interpret sampling test results.
- Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe).
Qualifications
- Bachelor’s degree in science (Chemical, Engineering, Biology, Pharmacy or Microbiology)
- Six (6) years of experience in project management, investigations or relevant roles and responsibilities.
in the pharmaceutical industry. - Fully bilingual (Spanish/English) communication skills, both written and verbal.
- Technical and scientific capability to make firm decisions and recommendations.
- Microsoft Office, SAP, Infinity.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Average salary estimate
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