Risk Management Associate I
927 S Curry Pike Bloomington, IN 47402 Bloomington, IN 47402 US
Target Pay Rate: 55-63k **salary will be commensurate with experience
The Technical Services Associate I (Risk Management) is responsible for risk management activities associated with non-conformances, complaints, equipment validation, qualification and change control activities at the site. This position interacts with clients, regulatory agencies and cross-functional teams (Engineering, Technical Services, Manufacturing, etc.) to ensure timely approval of all associated documents. This position reports to the Technical Services Validation Sr. Manager.
What you'll be doing:
- Provide guidance and technical expertise of regulatory and Baxter requirements in Risk Management strategies and processes.
- Assess risk associated with non-conformances complaints, audits, change control etc. and update the site process FMEA with new risks as needed.
- Approve risk forms submitted with newly identified risk submitted via non-conformance investigations, complaints, audits, change control etc.
- Author and/or approve applicable risk assessment documents for equipment and manufacturing process related changes.
- Author and/or approve applicable deviation reports for product and process related deviations.
- Help lead Risk Management activities for sustaining Engineering/Manufacturing projects
- Provide SME input to risk remediation activities.
- Support risk assessment of new processes to be validated.
- Uses statistical tools to analyze data.
- Performs annual reviews of all process FMEAs.
- Participates in regulatory inspections.
What you'll bring:
- Bachelor’s degree required, preferably in a science or engineering related field
- Pharmaceutical industry experience in parenteral manufacturing a plus
- American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification a plus.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Pilgrim, Trackwise, etc.)
Physical / Safety Requirements:
- Must be able to wear appropriate personal protective equipment.
- Duties may require overtime work, including nights and weekends
- Use of hands and fingers to manipulate office equipment is required
- Position requires sitting for long hours but may involve walking or standing for periods of time.
- Must be able to gown for Grade C area
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.