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Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Associate to join our team at Randstad. As a Quality Assurance Associate, you will be responsible for ensuring the quality of our products and services, and for maintaining compliance with regulatory requirements.
Key Responsibilities:- Document Control: Be responsible for the scanning and indexing of QC data and batch records into the SAP document retention software.
- Workflow Management: Evaluate and process new and revised document workflows in the electronic document management system, verify and assign approval panels on document workflows, and ensure open workflows are completed in an acceptable timeframe.
- Periodic Review: Be responsible for the assignment of periodic review tasks to responsible department assignees and ensure periodic review workflows are completed.
- Document Issuance: Issue manufacturing, packaging, and labeling documents to manufacturing per the schedule.
- Record Archival: Work to ensure accurate and timely record archival of site batch records and other quality records, including imaging and physical record management and calibration records.
- Education: High school diploma or GED with 1-2 years applicable experience in a QA job function as deemed appropriate by QA Management.
- Experience: Associate degree in Life Sciences, Chemistry, or other related subject or equivalent experience preferred.
- Skills: Knowledge of ISO 9001:2008 and ISO 13485 desired, knowledge of other regulatory requirements (i.e., USDA, FDA, EC, DEFRA, ICH, and EDQM) desired.
- Competitive Pay: Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc.
- Benefits Package: Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
