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Quality Assurance Specialist
3 months ago
Position: Quality Assurance Specialist
Location: Woburn, MA (Hybrid – 4 days onsite)
Length: 12+ months
Job Description:
Our client is seeking a detail-oriented and knowledgeable Quality Assurance Specialist to join their team. The Quality Assurance Specialist will play a crucial role in supporting various areas within UGT Quality Assurance, ensuring compliance with Good Manufacturing Practices (GMP) and maintaining high standards of documentation.
Essential Duties and Responsibilities (but not limited to):
- Demonstrate a solid understanding of Good Documentation Practices (GDP) and GMP principles in daily tasks.
- Conduct thorough reviews of GMP documentation, including Quality Control (QC) data packets and Certificates of Analysis (COAs).
- Assist in driving the timely completion of data packets and COAs to ensure efficient operations.
- Communicate effectively with team members and other departments to assess daily needs and priorities.
- Escalate issues and concerns to appropriate parties to ensure timely resolution and maintain project momentum.
- Support the quality management system and assist with quality project needs as required.
- Contribute to ongoing efforts to enhance quality processes and systems within the organization.
Qualifications:
- Bachelor’s degree is required.
- Proven experience in a quality assurance role, preferably in a GMP-regulated environment.
- Strong understanding of Good Documentation Practices and GMP principles.
- Excellent attention to detail with the ability to review and interpret complex documentation.
- Effective communication skills, with the ability to collaborate across departments and escalate issues as needed.
- Proficiency in standard office software and familiarity with quality management systems.
- Experience with QC data packets and Certificates of Analysis (COAs) is highly desirable.
- Previous experience working in a similar role within the pharmaceutical or biotechnology industry is a plus.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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