Quality Assurance Specialist I
About The Position
The Quality Assurance Specialist I supports ongoing compliance in manufacturing and distribution processes and may contribute throughout the product life cycle, including product design, manufacturing support, and post-launch maintenance. The role works with manufacturing and engineering on continual improvements to product and process quality, and applies sound quality principles and regulatory guidelines to decisions. The specialist oversees quality activities for assigned areas, including nonconformance management, investigations and corrective actions, CAPA effectiveness verification, quality metric trending, validation activities, quality documentation, and review and approval of operations records. The role also analyzes quality metrics to identify potential process improvements and prepares trend reports and presentations for management.
Requirements
- Bachelor's degree (BA/BS) in life sciences, physical sciences, engineering, or a related field.
- Experience in Quality Assurance or Quality Control within pharmaceutical or medical device manufacturing.
- Familiarity with 21 CFR 210, 211, and/or 820 and ISO 13485.
- Strong understanding of GMPs and regulated quality systems.
- Ability to trend, analyze, and graph data for presentation to management.
- Detail-oriented and well-organized.
- Ability to multitask and shift priorities as needed to meet operational requirements and customer demand.
- Must be authorized to work for any employer in the U.S.; the company is unable to sponsor or take over sponsorship of an employment visa.
Nice To Haves
- CQA, CQE, or CQM certification.
- Experience with nonconformance investigations and root cause analysis.
Responsibilities
- Participate with manufacturing and engineering in developing plans for continual improvement of product and process quality.
- Ensure decisions are based on sound quality principles and regulatory guidelines.
- Manage nonconformances for assigned areas of QA oversight.
- Assist with or perform failure investigations using root cause analysis tools, and propose or implement systemic corrective actions.
- Execute CAPA effectiveness verifications to confirm corrective actions are effective.
- Trend key quality metrics, including nonconformances.
- Prepare trend reports and presentations for management.
- Evaluate metrics to identify potential process improvements.
- Assist in implementing process improvements.
- Provide quality oversight of validation activities, including QA review and approval of validation documentation.
- Create and revise quality-related documentation.
- Review and approve operations records for assigned areas of quality oversight.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
