Quality Control Analyst

Job Title: Quality Control Analyst I
Location: Ridgefield, NJ
Duration: 24 months

Job 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.

What you will do:
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.