Quality Assurance Analyst

$41,600 - $45,760/Yr

Merck KGaA Darmstadt Germany - St. Louis, MO

Full-time - Entry Level

St. Louis, MO

Chemical Manufacturing

About the position

The Quality Assurance Analyst position at MilliporeSigma in St. Louis, MO, is a full-time, temp-to-hire opportunity that involves a comprehensive review of quality system documents to ensure adherence to Good Documentation Practices. The role requires collaboration with document owners to gather necessary information and documents, as well as the scanning and indexing of Quality Control (QC) data and batch records into the SAP document retention software. The analyst will evaluate and process new and revised document workflows within the electronic document management system, ensuring that approval panels are verified and assigned appropriately. Additionally, the analyst will oversee the assignment of periodic review tasks to relevant department personnel and ensure that these workflows are completed in a timely manner. The position also entails issuing manufacturing, packaging, and labeling documents to the manufacturing team according to a predetermined schedule. Regular interaction with production and laboratory personnel is essential to maintain effective communication and provide quality-related services to internal customers. The Quality Assurance Analyst will be responsible for the accurate and timely archival of site batch records and other quality records, which includes both imaging and physical record management, as well as calibration records. This role is critical in developing, improving, and executing processes related to documents used in an ISO 9001 and ISO 13485 quality system environment, contributing to various business-related initiatives.

Responsibilities

• Review quality system documents for Good Documentation Practices.
• Work with document owners to obtain necessary information and documents.
• Scan and index QC data and batch records into SAP document retention software.
• Evaluate and process new and revised document workflows in the electronic document management system.
• Verify and assign approval panels on document workflows and ensure timely completion of open workflows.
• Assign periodic review tasks to responsible department assignees and ensure completion of periodic review workflows.
• Issue manufacturing, packaging, and labeling documents to manufacturing per the schedule.
• Interact regularly with production and laboratory personnel to ensure effective communication and feedback for quality-related services.
• Ensure accurate and timely archival of site batch records and other quality records, including imaging and physical record management.

Requirements

• High school diploma or GED with 1-2 years applicable experience in a QA job function as deemed appropriate by QA Management.
• Associate degree in Life Sciences, Chemistry, or other related subject or equivalent experience preferred.
• Knowledge of ISO 9001:2008 and ISO 13485 desired.
• Knowledge of other regulatory requirements (i.e., USDA, FDA, EC, DEFRA, ICH, and EDQM) desired.
• Excellent computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint, and ability to learn and operate other specific application software required.
• Excellent communication (verbal and written) and writing skills, with experience in writing technical documentation and reports required.
• Customer interface skills and experience in using quality system applications such as Trackwise, Document Control, and/or ManGo.
• Ability to follow written instructions to complete tasks accurately.

Nice-to-haves

• Experience in the Pharmaceutical/Medical Device industry.
• Familiarity with Good Manufacturing Practices (GMP).
• Experience in Document Control.

Benefits

• Opportunities for career advancement and personal development.
• Supportive work environment that encourages curiosity and ambition.