Quality Analyst

Job Title: Quality Analyst (Deviation Investigator)

Location: Baltimore, MD.

Job Type: Long-term / Contract (40+hours)

Experience Level: Mid-level (5+ years of experience)

Job Summary:

• We are seeking an experienced Deviation Investigator to join our team in Baltimore, MD. The ideal candidate will have a strong background in quality assurance and deviation management within the pharmaceutical or biotechnology industry. The Deviation Investigator will be responsible for identifying, investigating, and resolving deviations in manufacturing processes to ensure compliance with regulatory standards and company policies.

Key Responsibilities:

• Conduct thorough investigations of deviations in manufacturing processes, including root cause analysis and impact assessment.
• Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs).
• Document findings and ensure all investigations are completed in a timely manner and in accordance with regulatory requirements.
• Review and approve deviation reports, ensuring accuracy and completeness.
• Monitor trends in deviations and work proactively to reduce their occurrence.
• Provide training and guidance to other team members on deviation investigation processes.

Qualifications:

• Bachelor’s degree in a related field (e.g., Life Sciences, Engineering).
• 6 years of experience in deviation investigation, quality assurance, or a related role in the pharmaceutical or biotechnology industry.
• Strong understanding of FDA regulations, cGMP, and other relevant guidelines.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work effectively in a fast-paced, dynamic environment.

Preferred Qualifications:

• Advanced degree or certifications in quality management.
• Experience with electronic quality management systems (eQMS).