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QA Documentation Specialist at QRC Group, Inc
Cidra, Puerto Rico, United States -
Full Time

Start Date

Immediate

Expiry Date

02 Jan, 26

Salary

0.0

Posted On

04 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

GMP Documentation, Quality Systems, Document Control, Attention to Detail, Organizational Skills, Written Communication, Cross-Functional Collaboration, Training, Regulatory Compliance, Internal Audits, Change Controls, CAPAs, Protocols, Batch Records, Document Readiness, Quality Standards

Industry

Staffing and Recruiting

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 Quality Assurance Specialist with strong expertise in GMP documentation and quality systems. This role blends traditional QA responsibilities with a focus on managing, reviewing, and controlling documentation to support compliance and operational excellence. Key Responsibilities: • Review, approve, and maintain GMP documentation including batch records, protocols, CAPAs, NOEs, and change controls. • Ensure documentation aligns with regulatory requirements and internal quality standards. • Support internal audits, inspections, and document readiness for regulatory agencies. • Collaborate with cross-functional teams to implement document revisions and updates. • Manage document control systems and ensure timely issuance and archiving of controlled documents. • Assist in training personnel on documentation procedures and compliance practices. Qualifications • Bachelor’s degree completed. • Minimum 5 years of experience. • Strong background in GMP documentation and quality systems. • Proficiency in document control platforms and Microsoft Office tools. • Excellent attention to detail, organizational skills, and written communication. • Ability to work independently and in cross-functional environments. Additional Information All your information will be kept confidential according to EEO guidelines.
Responsibilities
The QA Documentation Specialist will review, approve, and maintain GMP documentation to ensure compliance with regulatory requirements. This role also involves managing document control systems and collaborating with cross-functional teams for document revisions.