Technical Services Associate I (Risk Management)

Simtra BioPharma Solutions • Bloomington, IN

69d

About The Position

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 BPS 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.

Requirements

• 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.)

Responsibilities

• 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.

Benefits

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal and more
• Onsite Campus Amenities
• Workout Facility
• Cafeteria
• Credit Union

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees