Simtra BioPharma Solutions
Aseptic Manufacturing Risk Management Associate II
Bloomington, Indiana, United States · Mid
Sponsorship not specifiedDetected 2 days ago
ExcelProcess ImprovementGMPMicrosoft Office
About the role
- The Technical Services Associate II (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 reports to the Technical Services Validation Sr.
- Assess risks associated with non-conformances, complaints, audits, and change controls, and update process FMEAs as needed.
Responsibilities
- Lead and support risk management activities for engineering, manufacturing, and process improvement projects.
- Support risk assessments for new processes and validation projects.
- Initiate, lead, and manage CAPAs and Change Control activities.
- Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Requirements
- Bachelor's degree required, preferably in a science or engineering related field
- Minimum of 2 years pharmaceutical industry experience in parenteral manufacturing
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Pilgrim, Veeva, Trackwise, etc.)
- Must be able to wear appropriate personal protective equipment.
- Use of hands and fingers to manipulate office equipment is required
- Must be able to gown for Grade C area
Nice to have
- American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification a plus.
Skills
- Utilize statistical tools to evaluate and analyze risk and process data.
Compensation
- Perform annual reviews and updates of site process FMEAs to ensure continued effectiveness.
Benefits
- Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
Company info
- Provide guidance and technical expertise on regulatory requirements and company risk management processes.
Equal opportunity
- Simtra is proud to be an equal opportunity employer.
- Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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