Work Schedule

Environmental Conditions

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!