Position Summary

The Associate II, Lab Support, performs cGMP laboratory support activities including Sample Accessioning, Product Reserve management, Glassware Cleaning, Supply Inventory management, etc.  May also assist with Stability Studies and other QC initiatives. Performs all work under GMP conditions.  Provides customer support to QC analysts and works cross functionally with other departments

Essential Functions (ES) and Responsibilities

• Performs cGMP laboratory support activities such as:
• Customer support functions for QC laboratories such as cleaning glassware, , shipping samples, sample preparation, and administrative support.
• Providing QC functions for product, such as assisting with Stability, Appearance, and Reserve programs, sample accessioning, providing information to internal and external customers.
• Utilizes and adheres to cGMP practices in documentation and execution of job functions.
• Completes documentation to ensure compliance with specifications and procedures.
• Performs other assigned QC Lab Support initiatives.
• Performs, reviews and trains on processes performed within the department.
• Writes and revises technical documentation for department areas of responsibility such as SOP’s, Stability Protocols and Final Reports, Specifications, etc
• Trains to become an appearance inspector / performers appearance inspections.
• Trains on and perform Particulate Matter USP <788> testing.
• Interacts with others, both within and outside the department, to provide customer support on issues related to department functions.
• Ensures that assigned Laboratory Support areas meet all regulatory requirements by verifying procedures are being followed, all recordkeeping is current, proper maintenance occurs and new requirements are identified as they arise.
• Assists in other functions, as assigned by the Manager.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Preferred Experience

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.