Quality Assurance Analyst

1 day ago


Bellevue, United States Mudrasys Full time

Job Description:
Overview:
We are seeking a meticulous and results-driven Quality Assurance Analyst to join our team. This role is crucial in ensuring the quality and compliance of our products by evaluating processes and systems. The ideal candidate will have 1-6 years of experience in quality assurance, with a preference for those with experience in the pharmaceutical or medical device industries.

Key Responsibilities:
Evaluate and analyze quality data to identify trends, potential issues, and opportunities for improvement.
Assist in the development and implementation of quality assurance processes and procedures to ensure compliance with industry standards and regulations.
Conduct routine inspections and audits to assess adherence to Good Manufacturing Practices (GMP) and other relevant quality standards.
Review and validate quality documentation, including batch records, quality control reports, and deviation reports.
Investigate and resolve quality issues, including managing corrective and preventive action plans (CAPAs) and ensuring timely resolution.
Collaborate with cross-functional teams to address quality concerns and implement effective solutions.
Maintain accurate and comprehensive records of quality metrics, audit results, and compliance reports.
Monitor key quality performance indicators and prepare reports for management.
Participate in and support continuous improvement initiatives to enhance quality processes and systems.
Provide guidance and support to staff on quality assurance procedures and best practices.

Qualifications:
Bachelor's or Master's Degree in Pharmacy, Life Sciences, or a related field.
1-6 years of experience in quality assurance within the pharmaceutical or medical device industry is preferred.
Strong understanding of FDA regulations, GMP guidelines, and quality assurance best practices.
Excellent analytical skills with the ability to assess data, identify trends, and resolve issues.
Proficient in quality assurance software and tools.
Strong organizational skills with the ability to manage multiple tasks and priorities effectively.
Effective communication skills, both written and verbal, with the ability to interact with various stakeholders.
Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications:
Certification in Quality Assurance or a related field is a plus.
Experience with international quality standards and regulations is advantageous.



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