Quality Specialist III 77

Position Objective
Responsible for scheduling and hosting customer Quality compliance audits of BioReliance Quality Systems and laboratories and support areas and for coordinating with the operations group the BioReliance response to customer audits. To assist with the development, implementation and maintenance of professional material used in the conduct of customer audits in order to assist BioReliance in achieving its business goals.
Responsible for performing internal audits of BioReliance Quality Systems, laboratory and support areas in accordance with applicable regulations, guidelines, corporate polices and standard operating procedures Determines compliance to regulatory requirements (GLP and/or GMP) by interpreting regulations against vendor procedures and records. The QA Specialist is responsible for providing support to Quality System compliance aspects.
Responsible for performing vendor qualification audits of BioReliance suppliers in accordance with applicable regulations, guidelines, corporate polices and standard operating procedures. Determines compliance to regulatory requirements (GLP and / or GMP) by interpreting regulations against procedures and records.

Essential Functions

- Perform duties according to the principles of GLP and GMP

- Schedules and books customer audits with BioReliance operations groups as per established
procedures. Maintain site visit schedule.

- Hosts customer audits and coordinates audit activities (tours, interviews, document retrieval) with operations

- Liaises with customer representative prior to arrival. Send read-ahead material and other customer requested documents

- Enter audit information and audit observations in the Quality Management System data base. Generates BioReliance audit response letter

- Assist with the completion of Quality Questionnaires and surveys

- Performs internal audits of different functions / areas as per established schedule

- Coordinates performance of internal audit with function / area representative

- Reviews procedures, practices and records prior to the audit

- Reviews records and supporting documentation for auditing requirements

- Enters audit information in the Quality Management System data base and generates audit reports

- Follows through the audit observations until approval and closure

- Performs vendor qualification of BioReliance vendors as per established schedule

- Liaises with vendor representative prior to audit. Request read-ahead material and other applicable vendor documents

- Reviews vendor history and product history prior to audit

- Review records and supporting documentation for auditing requirements

- Review completed Vendor Questionnaires

- Enters audit information in the Quality Management System data base and generates audit reports

- Perform more inspection of more complex function areas and performs 'For Cause' audits of Vendors

- Follows through the audit observations until approval and closure

- Reviews SOPs/other documents for compliance requirements

- Enters applicable corrective actions from customer audit, internal audit and supplier audits into CAPA systems and follow through the actions until closure

- Tracks on-time and over-due audit responses

- Trains other QA Specialist as a Qualified Trainer

- Leads/implements/participates in projects with demonstrable process improvement and / or monetary savings to company

- Suggests revisions to quality procedures to improve efficiency/accuracy

- Other GLP/GMP duties as assigned

Nature and Scope:

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