Quality Control Analyst

Description:

How you will make an impact:

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

• Perform daily Viable and Non-viable EM in 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 corporation and regulatory agencies.
• Maintain all associated documentation for EM and operations being performed.
• Follow ALCOA+ principals 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 revision of EM standard operating procedures (SOPs) and batch production records (BPRs).
• Author and assist with out-of-specification and non-conformance EM investigations.

Willing to work extended hours and/or weekends to help support the production schedule. A reasonable amount of mandatory overtime is considered an essential job function. Mandatory overtime is part of your schedule and required to meet production needs and time missed will result in occurrences in accordance with company policy.

• It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.
• The individual must support all company and site EHS policies as well as ensure that work performed is compliant with local EHS regulations.
• Individuals must complete all required EHS trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility.
• Individuals must ensure timely closure of HSE actions owned by their departments.

Name:
Is a DEA Background Screen required for this position?

Value:
Yes

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