Quality Records Analyst - GMP & SAP Expert

(1023) Chattem, Inc; Chattanooga (TN); On-site; USD 26,000 - 37,000; Full time

Job summary

Opella seeks a Quality Assurance Records Analyst in Chattanooga, onsite. You will review batch documentation, audit records, and production logs to ensure completeness, accuracy, and regulatory compliance before release.

You will manage document control, support SAP-based release activities, and prepare COCs/COAs while coordinating archival and off-site storage. Join a global OTC/VMS leader focused on simple, smarter health.

Qualifications

• High School Diploma required.
• 3+ years’ experience with batch record documentation.
• Comprehensive knowledge of Document Control procedures and practices.
• Experience with SAP, MS Word, MS Excel, and MS Outlook.
• Strong interpersonal skills and attention to detail.
• Ability to multitask and adapt to scheduling changes.
• Good Documentation Practices and GMP experience.

Responsibilities

• Review batch documentation, audit records, and production logs for accuracy and compliance prior to product release.
• Approve and execute finished product release activities through SAP ERP; identify and escalate quality issues.
• Manage, centralize, and maintain quality and release documentation per regulatory and company requirements.
• Issue batch processing and packaging records to support manufacturing operations and production readiness.
• Administer document control systems, including new product setup, record scanning, archival prep, and off-site storage coordination.
• Prepare and support quality documentation, including Certificates of Conformance (COC) and backup preparation of Certificates of Analysis (COA).
• Provide cross-functional support through Document Control and Quality Assurance projects, serving as a trained backup for additional departmental responsibilities.

Skills

Attention to detail

Interpersonal skills

Multitasking

Self-driven

GMP experience

Batch record documentation

Document Control

Education

High School Diploma

Tools

SAP

MS Word

MS Excel

MS Outlook

Job description

Opella seeks a Quality Assurance Records Analyst in Chattanooga, onsite. You will review batch documentation, audit records, and production logs to ensure completeness, accuracy, and regulatory compliance before release.

You will manage document control, support SAP-based release activities, and prepare COCs/COAs while coordinating archival and off-site storage. Join a global OTC/VMS leader focused on simple, smarter health.