Quality Engineer Specialist, Quality Risk Management

AstraZeneca - Gaithersburg, MD

Full-time - Entry Level

Gaithersburg, MD

Chemical Manufacturing

About the position

Join our dynamic Operations team as a Quality Engineer Specialist in Quality Risk Management. In this role, you will provide in-depth understanding and application of pharmaceutical quality risk management practices and approaches in design and manufacturing environments. You will have the opportunity to demonstrate intimate working knowledge of pharmaceutical relevant standards, principles and best practices. This is a chance to work on diversified tasks with a global team, and be exposed to new ways of thinking, helping us to grow collectively and as individuals. As a Quality Engineer Specialist, you will facilitate and guide cross-functional team members in the use of available quality risk management tools, including FMEA, PHA, RR&F. You will collaborate with project teams and necessary departments to complete risk assessments and lead teams in identifying mitigations. You will evaluate product data for their impact on the current quality risk management files and author and review quality risk management plans, reports, and risk assessments. You will also ensure that all AstraZeneca policy and procedures for the Risk Management Program are followed at the site level.

Responsibilities

• Facilitate and guide cross-functional team members in the use of quality risk management tools such as FMEA, PHA, and RR&F.
• Collaborate with project teams and necessary departments to complete risk assessments.
• Lead teams in identifying mitigations for quality risks.
• Evaluate product data for their impact on current quality risk management files.
• Author and review quality risk management plans, reports, and risk assessments.
• Ensure compliance with AstraZeneca policy and procedures for the Risk Management Program at the site level.

Requirements

• Bachelor's degree in a technical discipline (Biology/Chemistry/Microbiology/Engineering or related field).
• Minimum of 2 years of experience in a pharmaceutical or FDA regulated environment.
• Familiarity with global regulatory agencies' requirements for Quality Risk Management and Quality Systems (ICH Q9, GAMP5, 21CFR 11/210/211).
• Ability to prioritize, manage, and follow-up on numerous projects and activities.
• Effective written and verbal communication skills.
• Excellent technical writing experience in a regulatory environment.
• Detail-oriented with a high degree of flexibility and initiative.
• Ability to function efficiently in a diverse, fast-paced, changing environment.
• Ability to work independently as well as part of a team.
• Ability to think critically and utilize troubleshooting and problem-solving skills.

Nice-to-haves

• Master's degree in a technical discipline (Biology/Chemistry/Microbiology/Engineering or related field).
• Cell and Gene Therapy experience is a plus.

Benefits

• Inclusive and equitable work environment.
• Opportunities for lifelong learning, growth, and development.
• Flexible working arrangements with a minimum of three days in the office per week.
• Reasonable adjustments/accommodations for candidates during the recruitment process.