Engineer III, QA
Engineer III, QA
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1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Job Summary:
We are seeking an experienced and meticulous QA Engineer III to join our Quality Assurance team as a Quality Validation Specialist. The ideal candidate will have a strong background in quality validation processes excellent analytical skills and a dedication to maintaining the highest standards of product quality. Typical work hours are Monday - Friday from 8a - 5p but the role also requires this individual to be available if needed for urgent off-hours questions.
Key Responsibilities:
Quality Validation: Govern validation activities for equipment processes computer software and cleaning validation ensuring compliance with industry standards and regulatory requirements.
Test Planning: Approve comprehensive test plans test cases and test scripts based on product requirements and specifications.
Execution and Reporting: Ensure oversight for execution of validation protocols and test cases and provide approval.
Continuous Improvement: Continuously review and improve validation processes and procedures to enhance efficiency and effectiveness.
Alignment: Ensure all validation activities align with company policies industry standards and regulatory requirements.
Collaboration: Work closely with multi-functional teams including development validation engineering product management and regulatory affairs to ensure quality objectives are met.
Training and Mentorship: Provide guidance and mentorship to junior QA engineers and contribute to the development of the QA team.
Qualifications:
Education: An Associates degree is minimally required; A Bachelors degree in Computer Science Engineering or a related field or an advanced degree is highly preferred.
Experience: Minimum of 5-7 years of experience in quality assurance in a pharmaceutical or similar GMP environment with at least 3 years in a quality validation role.
Technical Skills: Proficiency in validation tools and methodologies experience with automated testing frameworks and strong understanding of software development life cycle (SDLC).
Analytical Skills: Excellent problem-solving skills and attention to detail.
Communication: Strong verbal and written communication skills with the ability to effectively convey complex information to diverse collaborators.
Industry Knowledge: Familiarity with relevant industry standards and regulations (e.g. ISO FDA GMP) is highly desirable.
Certifications: Relevant certifications (e.g. ISTQB ASQ) are a plus.
We offer competitive salary an annual incentive bonus plan 401K with company match up to 6% tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation forward-thinking and an outstanding career and development prospects. Come be a part of the team!
Employment Type
Full-Time
