Quality Control Analyst

About the role

The Quality Control Analyst I performs environmental monitoring (EM) of aseptic manufacturing operations in Grade A, B, C, and D clean room environments and other classified areas as required.

Responsibilities

• Perform daily Viable and Non-viable EM in the production facility.
• Assist with manufacturing operations during periods of inactivity as required.
• Perform product sampling, EM, or other related activities as directed.
• Maintain batch record documentation and logs as required by the corporation and regulatory agencies.
• Maintain all associated documentation for EM and operations being performed, following ALCOA principles with right first-time, legible, and contemporaneous entries.
• Perform cleaning and sanitizing of EM equipment.
• Maintain supply/stock of required materials for EM operations.
• Prepare plates daily required for EM operations.
• Assist in process and system validation activities as required.
• Serve as witness to routine unit operational tasks for batch record signing.
• Review and revise EM standard operating procedures (SOPs) and batch production records (BPRs).
• Author and assist with out-of-specification and non-conformance EM investigations.

Requirements

• Willing to work extended hours and/or weekends to support the production schedule. Mandatory overtime is considered an essential job function and is required to meet production needs.

Environment, Health and Safety (EHS) Requirements

• Promote a safe working environment and ensure compliance with company/site EHS policies and local EHS regulations.
• Complete all required EHS trainings.
• Report all accidents and incidents and support investigations in assigned areas.
• Ensure timely closure of HSE actions owned by their departments.

Individuals must care for their own safety and wellbeing while supporting EHS initiatives.