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QRC Group, Inc

Specialist QA

QRC Group, Inc Juncos, Puerto Rico

Staffing and Recruiting · 51-200 employees

4 h ago
qa Mid (2-5 yrs) Contractor Puerto Rico
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About the role

The QA Specialist will support quality and manufacturing operations by performing comprehensive batch record reviews and ensuring compliance with GMP and GDP requirements. They will also manage electronic systems, oversee inventory control, and participate in operational meetings to facilitate risk-based quality decisions.

What they look for

Batch record review GMP GDP Data integrity SAP Inventory management Material reconciliation PAX Electronic batch record Quality compliance Risk-based decision making Manufacturing operations Communication Problem-solving Organizational skills

Requirements

Candidates must hold a Doctorate or Master's degree with 2 years of experience, or a Bachelor's degree with 4 years of experience in a GMP-regulated environment. Proficiency in SAP, electronic batch record systems, and strong knowledge of data integrity and quality compliance are required.

Full 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!

Job Description

We are seeking a QA Specialist to support Quality and Manufacturing operations through batch record review, GMP documentation compliance, electronic systems management, inventory control, and quality decision-making. The ideal candidate is detail-oriented, able to work independently in a fast-paced environment, and possesses strong communication, organizational, and problem-solving skills.

Qualifications

  • Education: Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience.
  • Perform comprehensive Batch Record Review to ensure completeness, accuracy, compliance, and adherence to approved procedures and GMP requirements.
  • Experience performing Batch Record Review in a GMP-regulated environment.
  • Strong knowledge of GMP, GDP, and Data Integrity requirements.
  • Experience with SAP inventory management and material reconciliation.
  • Experience using PAX and/or Electronic Batch Record (eBR) systems.
  • Ability to assess quality/compliance issues and apply risk-based decision making.
  • Experience participating in manufacturing and quality operations meetings.
  • Strong organizational skills and ability to manage multiple priorities with minimal supervision.
  • Fully Bilingual (English & Spanish).

Additional Information

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

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