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Doc Control Coordinator - Career in Hayward, CA at Volt

Date Posted: 2/12/2019

Job Snapshot

Job Description

Quality Assurance Specialist

The QA Specialist works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. They use professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways. They exercise judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions. They do not require instructions on routine work and follow general instructions on new assignments.

Essential Job Responsibilities:

Primary duties and responsibilities include:

Review quality documents (including but not limited to component and manufacturing batch records as well as product labels, technical data sheets, product release test and retest data, certificates of analysis, calibration records and other documents) for accuracy, completeness, authenticity and compliance with established procedures and the Quality System. Releases components and products to inventory ensuring all requirements for Quality are met. The batch record review metrics are analyzed and provided in reports to the Director.

Perform quality document revisions and upgrades under the ProZyme Quality System focusing on controlled documents (WSRs, BPRs, PPRs, etc...). Routes documents for review through Q-Pulse, tracking approvals for timely review and final approval of new documents and revisions. Tracks and trends documentation metrics.

In addition, the QA Specialist:

Assists the Director of Quality Systems with performing internal audits, follow up and implementation of corrective and preventive action and other quality improvements and to ensure corrective actions are completed in a timely fashion.

May be asked to assist with customer and regulatory audits and with the tracking and implementation of timely corrective actions.

Administers and maintains Q-Pulse (QMS database). Trains others in Documentation Standards and Batch Record Review.

Maintains the Batch History Files and other quality records.

May administer Pipette Proficiency Testing Program.

Performs routine tasks with no supervision and with general instructions on new assignments.

Other tasks as assigned by the Director of Quality Systems.

Requires a university degree (or equivalent) and a minimum of 5-7 years of related experience. Requires a minimum of 3 years directly related experience, with typically 6 to 8 years experience.

Someone with ISO 9001 or FDA Quality System Regulation's (QSR's) experience is preferred.

Must be experienced in word processing and spreadsheet programs. The position requires attention to detail and ability to determine if procedure or policy requirements are met.

Must be a strong team player to interact with other departments to ensure compliance to the policies and procedures.

Volt is an Equal Opportunity Employer