Job Description

Job Title: Quality Assurance Analyst
Duration: 12 months
Location: Elkton, VA 22827

Job Description:

Responsibilities:

• Provide technical support for sterile manufacturing processes through data analysis, troubleshooting, problem-solving, report writing, and shop-floor support.
• Support change control implementation.
• Collaborate with cross-functional teams across various levels.
• Learn and adapt to new processes and procedures.
• Perform shift work as needed (expected to be minimal).
• Conduct technical investigations and analyses.
• Recommend and implement corrective and preventative actions, contributing to the reduction of atypical events.
• Write, review, and improve procedures for the operation of equipment and processes.
• Contribute to process and equipment safety reviews.

Qualifications and Required Skills:

• B.S. or M.S. degree in biology, biochemistry, biochemical engineering, biological systems engineering, biomedical engineering, chemical engineering, computer science, integrated science, or related disciplines.
• 0-3 years of relevant industrial experience.
• Shift Hours: Primarily ~8:00 AM – 5:00 PM Monday–Friday, occasionally working longer hours or until 10:30 PM (~2-3 weeks/year). Beta Lactam requirement applies (candidates must not have known allergies).
• Excellent academic record.
• Strong verbal and written communication skills, teamwork abilities, personal character, and ethics.
• Proficiency in problem-solving with a hands-on approach, including a preference for direct field observation.
• Ability to assess issues from diverse perspectives (e.g., safety, compliance, maintenance, automation, equipment, process, and people) for optimal resolution.
• Enthusiasm, confidence, and proactive learning capability.
• A strong desire to succeed and help others achieve success.

Heavily Preferred Experiences:

• Experience working in a cGMP environment.
• Work, co-op, or internship experience in the industry.

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