Quality Systems Specialist — cGMP Documentation & Change Control

QuVa Pharma, Inc.; Sugar Land (TX); On-site; USD 60,000 - 85,000; Full time

Job summary

QuVa Pharma, Inc. is seeking a Quality Systems Specialist to ensure high quality and safety standards for pharmaceutical products.

You will maintain and coordinate quality system documents for cGMP compliance, process changes in batch records through Change Control, and issue up-to-date procedures, forms, and batch records with minimal supervision. The role is full-time on-site at Sugar Land, TX, with a set Monday–Friday schedule, and involves working on a robust quality management framework

Qualifications

• High school diploma or GED is required.
• 1+ year of experience is preferred; 6 months to 1 year at Quva Pharma is noted.
• Understanding of archival processes and document controls is preferred.
• Must be 18+ years of age.
• Must pass drug and background checks.
• Authorized to work in the United States on a full-time basis; visa sponsorship is not available.
• Experience in FDA-regulated operations or GMP-related environments is a plus.

Responsibilities

• Review and write document change requests.
• Coordinate updates to procedures, forms and batch records across departments.
• Maintain quality management systems and document workflows.
• Generate workflows for document creation, revision and implementation.
• Ensure documents have current version at all times.
• Assist with audits by retrieving documents and information.
• Coordinate procedure effective dates with training department.
• Act as administrator of controlled documents for Quality functions.
• Participate in process improvements and projects.

Skills

Attention to detail

Verbal and written communication

Education

High school diploma or GED

Bachelor’s Degree in life science

Tools

Microsoft Office

Adobe

Word

Excel

Job description

QuVa Pharma, Inc. is seeking a Quality Systems Specialist to ensure high quality and safety standards for pharmaceutical products.

You will maintain and coordinate quality system documents for cGMP compliance, process changes in batch records through Change Control, and issue up-to-date procedures, forms, and batch records with minimal supervision. The role is full-time on-site at Sugar Land, TX, with a set Monday–Friday schedule, and involves working on a robust quality management framework