eNewsletter Signup
Miles
Km80.5

Compliance Investigator

Hospira, Inc.

Apply
E-Mail to a Friend Add to Job Folder View All Jobs Back to Search Results Share
Location: Austin, TX Posted Date: 5/3/2013 Position Type: Full time Job Code: 11336BR Required Education: Bachelors Degree

Description

Primary Function:  The Compliance Investigations Department manages the Austin investigations program. The department staff writes and reviews exception documents for compliance to procedures. The Compliance Investigator will: Write, coordinate, develop, track and manage investigations per procedures.     Assure all exception documentation adequately address root cause, corrective  preventive actions and product impact.   Major Duties and Responsibilities: Write investigations for exceptions, excursions from procedures and nonconforming events.      Ensure root cause, corrective action, preventive action and product impact are thoroughly addressed in investigations.     Document investigations in a format that ensures the requirements of procedures are reflected.       Provide training and conduct verification assessments to ensure adequate maintenance of quality systems and processes.     Manage projects to ensure that they are completed within the required time schedule as required per quality systems     Provide support activity during regulatory or 3rd party audits.     Prepare investigation statistics as requested.     Ensure accurate project schedules are maintained and communicated to management.     Benchmark with others to assimilate the best practices for compliance. Conduct gap analysis for GMP compliance, trending and report on quality data to support continuous improvement initiatives.     Participate on committees/teams supporting GMP compliance programs.     Utilize trend data to develop schedule and incorporate into facility investigations.     Participate in Regulatory inspections, as required.

Requirements

Skills/Experience/Education:- Must have a Bachelor's degree in Engineering, Science or Manufacturing.- Minimum of 5 years experience in Quality, Manufacturing, Engineering, or RD functions or any combination of the above.- Must have working knowledge of Good Manufacturing Practices and regulatory requirements.- Prefer experience in the following areas: Complaint or Inspection Writing, Validation principles; Pharmaceutical manufacturing methods; Documentation systems, Quality Systems; analytical, or microbiological testing principles.- Two years experience in project management and quality engineering principles.- A working knowledge of Quality tools, such as statistical quality control.- Strong communication and organizational skills.- Ability to communicate with all levels of management.
Apply
E-Mail to a Friend Add to Job Folder



By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.

ADVERTISEMENTS