Main Purpose of Position:

We are currently seeking a QA Auditor/Sr. Auditor to be responsible for a variety of QA auditing activities. 

Main Duties and Responsibilities:

Primary responsibility for auditing program, which includes:

• QA assessment of material and service suppliers
• Maintenance of the approved suppliers list (ASL)
• Performing supplier external audits as needed

Manage Internal Audit program:

• Issue audit calendar
• Arrange audit teams
• Assure audit activities and responses are carried out

• BA/BS degree in a scientific discipline or equivalent
• Knowledge of cGMP for pharmaceuticals (21 CFR 211 and EU regulations), Knowledgeable of ANSI / ASQC sampling procedures
• Knowledge of QSR for Medical Devices, ISO 9000 requirements, Good Laboratory Practices (GLP) and Controlled Substances a plus
• Must have five or more years relevant experience in pharmaceutical or biotech Quality Assurance
• Internal audit and audits of external suppliers
• Strong writing, verbal and interpersonal communication skills
• Excellent attention to detail
• Excellent analytical and problem solving skills
• Proficient computer skills
• High commitment to assignments and capability of working independently
• Able to remain focused in a constantly changing environment

Working Conditions:

• Moderate travel required
• Light physical effort.  Requires handling of average weighted object up to 10 pounds or some standing or walking
• Work is normally performed in a typical office work environment / some warehouse work is needed
• Work environment involves minimal exposure to physical risks such as operating dangerous equipment or working with chemicals

IMPORTANT: In the subject line of your email please include your SURNAME, FIRSTNAME, followed by 542Jun06-4 (copy and paste). Your submission MUST contain this exact job-number, NOT THE JOB TITLE, in order to be properly routed and considered .

DURECT Corporation is an Equal Opportunity Employer

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