Job Opening - Senior Quality Auditor
G & W Labs - South Plainfield, NJ

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Job Opening - Senior Quality Auditor

Position Purpose: This position is responsible for scheduling and performing external audits for G&W's QA Compliance group, hosting customer audits, and maintaining a Supplier Qualification program. Audits will include GMP, GLP, GCP audits (internal/external), due diligence audits. The External audit scope will consist of excipient/API/component suppliers, contract laboratories, computer software suppliers, and contract manufacturers and CRO's.

Principal Accountabilities:

Schedule, perform, document, make observations, write reports, and follow-up on audits of domestic and foreign suppliers of active pharmaceutical ingredients, excipient raw materials, packaging components, contract laboratories, computer software suppliers, CRO's, and contract manufacturing service providers that are being used or considered for use as manufacturers or packagers of drug product

Manage a Supplier Qualification program

Maintain quality records of all audits

Generate metrics/trending charts from audits performed

Required Skills:

Experience (both internal and external) auditing manufacturing facilities, equipment, laboratories, clinical sites, and service providers

A working knowledge of pharmaceutical manufacturing processes

A working knowledge of pharmaceutical testing laboratory procedures and instruments

A working knowledge of the current GMP's, GLP's, and GCP's and the ability to apply that knowledge to assure that providers of materials and services are compliant

Excellent verbal and written and organizational skills. The position requires that the employee communicate with internal and external management groups in order to assure that non-compliant conditions noted during audits are addressed

Ability to get Visa required for travel to foreign audit sites

Ability to perform audits in industrial or laboratory settings

Ability to travel for up to two weeks at a time both foreign or domestically (travel is approximately 15% of time)

Strong computer skills, Microsoft Office Applications (Access, Excel and Word)

Ability to follow through and consistently demonstrate that all primary job duties and responsibilities are current and up to date; ability to closely monitor and communicate progress to Management

Must be able to work as a team member, maintaining day to day activities while being responsive to changing priorities

Must be able to work a consistent schedule to satisfy the responsibilities of the job

Knowledge of electronic document systems

E ducation and Experience:

A Bachelor's Degree in a scientific discipline.

A minimum of 5 - 7 years auditing experience in regulatory compliance/quality assurance in the pharmaceutical industry

G & W Labs - 19 months ago - save job - block
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