Engineer III, QA Position Available In Pitt, North Carolina
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Job Description
Work Schedule Standard (Mon-Fri)
Environmental Conditions Office Job 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 Associate’s degree is minimally required; A Bachelor’s 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!