Offers “Abbott”

Expires soon Abbott

Sr Internal Auditor - Transfusion

  • Lake Forest (Orange)
  • Auditing

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

This position administrates regulatory compliance activities related to the Internal Audit Program. The position is key in the facilitation/execution of the internal inspection process and ensures the Internal Audit Program across the Abbott Transfusion Medicine (ATM) Division serves to identify Quality System improvements. Independently conducts assigned audits of other Abbott Diagnostic Division (ADD) suppliers for the ATM Division to assess compliance to all applicable External Standards and Regulations as well as Abbott Quality System Requirements.

Responsibilities:

• Carries out assigned duties and tasks related to area of responsibility with management guidance, may be responsible for decision making.

• May mentor less senior level members of the group.

• Conducts internal audits across the ATM Sites to assess compliance to all applicable External Standards and Regulations as well as Abbott Quality System Requirements.

• Independently conducts and leads audits across ATM internal supplier sites.

• Identifies compliance risks to current standards / regulations and may guide in the planning and execution of Quality System improvements.

• Prepares and implements Internal Audit schedules spanning the ATM manufacturing sites.

• Uses current regulatory trends to identify potential compliance risks or opportunities for improvement in ATM's Quality System.

• Conducts internal audits at a standard commensurate with regulatory external audits.

• Reports progress of audits within Sites and to Division personnel as appropriate.

• Provides guidance to applicable “Inspection-Readiness” activities across ATM Sites.

• Performs topic specific SIM audits at ATM Sites as requested by management.

• Reports audit findings in a timely manner.

•Tracks the progress and completion of audit CAPA plans.

• Generates and reports internal audit metrics to Site and Division Management.

• Maintains files and documentation associated with internal and external inspections.

• May assist with audit support activities during external audits of Sites.

• The above statements are intended to describe the general nature and level of work that is being performed.

• Other duties may be performed as assigned.

Qualifications:

• Certified Auditor qualification or equivalent is required

• Degree preferably in Science or technical discipline such as biology, chemistry, engineering or Certification in Medical Technology or Quality Management.

• Trained at a minimum as a Certified Auditor with working knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820, 21 CFR Part 600, ISO 13485, and IVDD.

• Minimum of 5 years' experience in pharmaceutical or medical device industry or other regulated industry.

Preferred Qualifications:

• Experience with FDA CBER and Team Biologics inspections for biologics licensed products.

• Familiarity with In-Vitro Diagnostic Regulation

JOB FAMILY:

Operations Quality

DIVISION:

ATM Transfusion

LOCATION:

United States > Lake Forest : CP01 Floor-3

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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