QUALITY ASSURANCE ASSOCIATE- 2ND SHIFT

Cambridge Major Laboratories, Inc. Germantown, WI 4/30/2013

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Job Description

Specific responsibilities to this position

Review of executed Batch Production Records / Batch Cleaning Records
Generation of protocols and final reports as assigned
Revision and routing of Standard Operating Procedures (SOPs)
Understand and interpret analytical data
Conduct analytical data review and release(raw materials, cleaning, stability, in-process, release, reference standard, validation)
Maintain proper document archival
Perform Internal and / or external auditing
Adhere to training requirements and maintain training file. Review of all documentation associated with the release of reference standards, raw materials, intermediates, and final products for use in GMP production
Generation of labels and Certificates of Analysis (COAs)
Review and routing of test methods and specifications related to GMP operations
Facilitate shipment of GMP Intermediates and APIs
Work on special projects assigned by Department Head(s).
Request, utilize, review, and route change controls
Manage and track projects assigned by supervisor
Facilitate ongoing improvement of processes to enhance overall quality

Job Requirements

Requires four-year degree (BS) in a science discipline or a four-year degree plus a minimum of 1 year of quality or analytical experience preferably in an FDA regulated environment.
Must be able to work 2nd shift

Key words: Quality, Analytical, Quality Assurance

Job Snapshot

Employment Type Full-Time

Job Type Manufacturing, QA - Quality Control

Education 4 Year Degree

Experience At least 1 year(s)

Manages Others No

Required Travel Not Specified

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