MFG Documentation Associate

Medivant Healthcare; Chandler (AZ); On-site; USD 55,000 - 60,000; Full time

Job summary

Medivant Healthcare in Chandler, AZ seeks a MFG Documentation Associate to support manufacturing compliance and batch release through document review, ERP transactions, data management, and production documentation.

The role ensures accuracy, audit readiness, and adherence to cGMP, FDA, and company quality standards. Bachelor's degree and 2–4 years in GMP environments are preferred.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or related field.
• 2–4 years of experience in pharmaceutical manufacturing or GMP environments.
• Strong attention to detail and organizational skills.

Responsibilities

• Review BMRs, logbooks, and GMP documents for accuracy and compliance.
• Support timely batch release through documentation review and submission.
• Compile validation and qualification documentation for manufacturing equipment.
• Issue and maintain manufacturing documents, forms, and logbooks.
• Create BOPs and complete ERP manufacturing transactions.
• Maintain batch records, yield data, and production trackers.
• Coordinate documentation activities for visual inspection and packaging operations.
• Support training coordination and audit readiness activities, including GEMBA walks.
• Ensure compliance with cGMP, GDP, safety and quality requirements.
• Support hazardous waste management in accordance with environmental regulations.

Skills

Attention to detail

Organizational skills

Documentation review

Education

Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or related field

Tools

ERP systems

GMP documentation

Job description

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MFG Documentation Associate

Chandler, AZ, US

Salary Range: $55,000.00 To $60,000.00 Hourly

Position Summary

The Manufacturing Documentation Associate supports manufacturing compliance and batch release activities through document review, ERP transactions, data management, and production documentation. This role ensures accuracy, audit readiness, and compliance with cGMP, FDA, and company quality standards.

Key Responsibilities

Documentation & Compliance

• Review BMRs, logbooks, and GMP documents for accuracy and compliance.
• Support timely batch release through documentation review and submission.
• Compile validation and qualification documentation for manufacturing equipment.
• Issue and maintain manufacturing documents, forms, and logbooks.

Manufacturing Support

• Create BOPs in Progen and complete ERP manufacturing transactions.
• Maintain batch execution records, yield data, and production trackers.
• Coordinate documentation activities for visual inspection and packaging operations.
• Support training coordination and audit readiness activities, including GEMBA walks.

Quality & Environmental Compliance

• Ensure compliance with cGMP, GDP, safety, and quality requirements.
• Support hazardous waste management in accordance with environmental regulations.
• Perform additional duties as assigned.

Qualifications

Required

• Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
• 2-4 years of experience in pharmaceutical manufacturing, documentation, or GMP-regulated environments.
• Experience reviewing batch records and GMP documentation.
• Strong attention to detail and organizational skills.

Preferred

• Experience in pharmaceutical manufacturing or GMP-regulated environments.
• Familiarity with ERP systems and manufacturing documentation.
• Knowledge of cGMP, GDP, and FDA requirements.
• Documentation Management
• Batch Record Review
• cGMP Compliance
• Data Integrity
• ERP Systems
• Audit Readiness
• Attention to Detail
• Organization & Planning

What Success Looks Like

• Batch documentation is reviewed accurately and submitted on time.
• Manufacturing records and ERP transactions are maintained with accuracy and compliance.
• Audit readiness and quality standards are consistently maintained.
• Documentation supports efficient manufacturing operations and timely batch release.