Description

You will provide technical guidance and leadership to maintain and improve site operations quality standards.

Responsibilities

• Provide direct quality oversight for production, engineering, automation, and laboratory operations.
• Review and approve procedures, change control proposals, deviations, and equipment/system qualification or validation.
• Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems.
• Conduct gap assessments of global requirements to ensure implementation of governing standards.
• Lead or support self-inspection activities and regulatory inspections.

Required Skills

• 2+ years of manufacturing experience.
• Technical understanding of quality systems and regulatory requirements.
• Experience in root cause analysis and application of statistical skills.
• Experience with system and equipment qualifications.
• Knowledge of cGMPs and quality systems.
• Experience in API or finished product manufacturing, QA, or Engineering.
• Proficiency with computer system applications and process automation systems.
• Knowledge of BDMS, utilities, and facilities/equipment qualification.

Preferred Skills

• BS in Engineering or a science-related field.

Key Skills

Education

Any Graduate