Job Description

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!


Specialist QA with experience in regulated industries to perform the following duties and responsibilities in support of Quality Assurance program. Duties and Responsibilities:

• Perform sampling plans for all manufactured products
• Batch record review
• SAP transactions
• Trackwise system queries, deviations
• Participate in triage process
• Perform oversight of the process and procedures/GMP tasks
• Compliance review of batch record elements (e.g., MPs, MSRs) and identification of discrepancies
• Participate in internal plant audits
• Work with operations to resolve basic compliance discrepancies

Qualifications

• Doctorate or Master\'s degree and 3 years of directly related experience or Bachelor\'s degree and 5 years of directly related experience or Associate\'s degree and 10 years of directly related experience
• Bilingual (Spanish/English) (Oral/Written)
• Technical writing
• Computer Literacy
• Strong organizational skills, including ability to follow assignments through to completion.
• Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
• Microsoft Office spreadsheet and application skills and presentation knowledge
• Fully Bilingual in (English and Spanish) (Written and Oral)
• Availability to work 3rd shift (Non Standard Shift 5:00PM-5:30AM)

Additional Information
All your information will be kept confidential according to EEO guidelines.