Simtra BioPharma Solutions

CAPA Manager

Bloomington, Indiana, United States

Sponsorship not specifiedDetected 12 days ago

Data VisualizationExcelGMPFDA RegulatoryMedical DevicesProblem SolvingMicrosoft Office

About the role

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide.
As such, there is a strong emphasis on quality and continuous improvement at Simtra.

Lead and facilitate investigations for deviations.
Utilize structured problem-solving tools (e.g., 5 Whys, Fishbone, FMEA) to identify root causes and implement effective corrective/preventive actions.
Trend overall CAPA metrics and perform root cause analysis on system performance to identify systemic issues and drive continuous improvement.
Support internal, client, and regulatory audits related to CAPA activities.
Partner with Manufacturing, Technical Services, Quality functions, and Engineering to ensure alignment and timely resolution of CAPA actions.
Drive continuous improvement initiatives to strengthen the CAPA system and overall quality performance.
Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Strong knowledge of cGMP, FDA, EMA, and ICH guidelines.
Proven experience managing CAPA systems and leading investigations.
Demonstrated ability to analyze and interpret quality data, trend metrics, and identify systemic issues using analytical tools.
Bachelor's degree required, preferably in a science-related field with a minimum 5 years of pharmaceutical or medical device industry experience, including management experience OR master's degree with 3 years of pharmaceutical or medical device industry experience
Familiarity with electronic quality management systems (e.g., Veeva, TrackWise) and Microsoft Office Suite; experience with data visualization or reporting tools (e.g., Excel advanced functions, Power BI) is a plus.

Familiarity with electronic quality management systems (e.g., Veeva, TrackWise) and Microsoft Office Suite
experience with data visualization or reporting tools (e.g., Excel advanced functions, Power BI) is a plus.

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

With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.

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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This listing is sourced directly from Simtra BioPharma Solutions's careers page and normalized into a canonical job model.