Senior Support Specialist- Lab Operations

Senior Support Specialist supporting laboratory operations and quality system validation at a pharmaceutical manufacturing site. Responsibilities include executing validation activities, managing purchasing processes, conducting investigations, and maintaining compliance with cGMP regulations and company policies.

Responsibilities

• Plan and execute validation activities for equipment, utilities, facilities, and analytical methods
• Audit documentation and lead investigations into validation failures with corrective actions
• Process purchasing requisitions and shopping carts in SRM/ECC systems
• Draft, review, and approve laboratory standard operating procedures
• Maintain change control programs for validated systems and support new installations

Requirements

• High school diploma or GED
• 6+ years manufacturing, quality, or engineering experience
• Knowledge of quality/compliance management and API/bulk drug/finished goods regulations
• Strong verbal and written communication skills
• Problem-solving and analytical capabilities
• Negotiation skills
• Technical school certification preferred