Quality Assurance Specialist I
About The Position
The Quality Assurance Specialist I supports ongoing compliance across 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 improvement of product and process quality, applying sound quality principles and regulatory guidelines. Responsibilities include overseeing nonconformances in assigned areas, assisting with failure investigations and root cause analysis, proposing and implementing systemic corrective actions, and verifying CAPA effectiveness. The specialist trends key quality metrics, prepares reports and management presentations, identifies opportunities for process improvement, and helps implement improvements. The role also provides quality oversight of validation activities, including review and approval of validation documentation, and creates or revises quality documentation and reviews and approves operations records. The position may be located at the Greenville, South Carolina plant. Applicants must be authorized to work for any U.S. employer; visa sponsorship is not available.
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.
- Detail-oriented and well-organized.
- Ability to multitask and shift priorities effectively to meet operational requirements and customer demand.
- Authorization to work for any employer in the United States; 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.
- Ability to trend, analyze, and graph data for presentation to management.
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 management presentations.
- Evaluate metrics to identify potential process improvements and assist in implementing improvements.
- Provide quality oversight of validation activities in assigned areas, including 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
