Quality Control Analyst
eTeam · Ridgefield, NJ · Yesterday
On-siteQuality AssuranceContract
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 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.
Location: Ridgefield, NJ
Duration: 24 months