QA Specialist I
About The Position
The Quality Assurance Specialist provides expertise in one or more specialized areas of the Quality Management System (QMS) and plays a critical role in ensuring compliance with GMP and regulatory requirements. This position serves as a key Quality Assurance representative for customer and regulatory audits, partnering with internal teams to host inspections conducted by client organizations and regulatory agencies. The role is essential in maintaining audit readiness, demonstrating the organization's commitment to quality, and fostering customer confidence through successful audit execution. The Quality Assurance Specialist also participates in cross-functional meetings, provides quality guidance, and serves as a QA contact for company-contracted services.
Requirements
- Thorough knowledge of applicable GxP regulations and regional regulatory requirements.
- Firm knowledge of the clinical trial process.
- Demonstrated experience supporting and hosting customer and regulatory audits in a GMP environment.
- Strong customer-facing communication, presentation, and relationship management skills.
- Ability to coordinate cross-functional teams to ensure audit readiness and successful inspection outcomes.
- Good knowledge of SOPs and WPDs.
- Excellent oral and written communication skills.
- Strong attention to detail and organizational skills.
- Effective problem-solving and time management skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Strong computer skills and ability to quickly learn quality systems and business applications.
- Proven flexibility and adaptability.
- Valid driver's license and ability to qualify for and maintain a corporate credit card for business travel.
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
Responsibilities
- Provide support to nearly every audit through a combination of pre-audit preparation, day of audit logistics and hosting, and post-audit follow-up
- Stage records as outlined in audit agenda
- Be present in audits to answer questions and fulfill document requests
- Monitor responses to audit findings to ensure they are provided to client by defined due date
- Provide support during regulatory inspections
Benefits
- Relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
