Manufacturing Quality Associate

Company Name:
Pinpoint Pharma
The Manufacturing Quality Associate position will perform a variety of tasks to analyze pharmaceutical compounds, inspect incoming supplies and release OEM product. A Manufacturing Quality Associate is expected to possess a familiarity with medical device manufacturing documentation review and release. Perform and/or assist with tasks required to oversee the proper operation and monitoring of the documentation from manufacturing clean room facility and QC lab operations as directed by the Manufacturing Quality Supervisor. Oversee and/or assist with tasks related to the activities associated with the operation of the company's Quality System and as directed by immediate supervisor and Quality Management.
Ensure timely QA review of documentation to verify compliance to SOPs and regulatory requirements.
Perform final review and release of finished Medical Device History Records.
Write, revise, and review SOPs for department.
Perform QA on the floor activities (e.g. verifications, inspections, etc.).
Ensure quality and consistency in documentation and adherence to SOPs.
Maintain expertise in quality systems (e.g. change control, critical system, etc) and ability to initiate and execute change control requests.
Assist with continuous improvement initiatives / projects.
Ensure training requirements are met and records are up to date.
Maintain and update departmental metrics and reporting.
Work closely with the Manufacturing department to provide on-going Quality support.
Represent QA at cross-functional meetings, providing QA input and decision making.
Identify and open Nonconformance Reports.
High school diploma required.
BS/BA in a Physical Science or related field preferred.
Minimum of 3-5 years experience in the medical device field or other Quality Control/Quality Assurance trade.
Date: 2014-08-29
Country: US
State: WI
City: Franksville
Postal Code: 53126

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