QA Engineer

Job Description:

Qualifications

• BS in Engineering or science-related field.
• GMP manufacturing knowledge and/or experience.
• 2+ years manufacturing experience.
• Thorough technical understanding of quality systems and regulatory requirements.
• Demonstrated coaching and mentoring skills.
• Experience in root cause analysis.
• Demonstrated application of statistical skills.
• Experience in API or finished product manufacturing, QA or Engineering.
• Experience with system and equipment qualifications.
• Knowledge of cGMPs and quality systems.
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Demonstrated flexibility when faced with changing priorities.
• Proficiency with computer system applications and process automation systems.

Responsibilities

• The Engineer – QA is responsible for providing technical guidance and leadership to the LP1 site regarding the quality standards employed to maintain and improve site operations
• The area of focus includes utilities, bulk distributed materials (BDMs), and facilities/equipment qualification
• Provide direct quality oversight of production, engineering, automation, and laboratory operations
• Review and approve documents including, but not limited to, procedures, change control proposals, deviations, and equipment/system qualification/validation
• Provide coaching, feedback and mentoring to engineering and QA as it relates to execution of quality systems
• Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems
• Conduct gap assessments of global requirements and ensure implementation of the governing standards
• Participate in and/or lead, support self-inspection activities and regulatory inspections
• Maintain and improve FUME quality systems
• Assist business partners in the interpretation of regulatory and corporate requirements