Quality Assurance Associate I - Aseptic Manufacturing

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Plan with Company Match

Paid Time Off

Flexible Spending Accounts

Education Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana is seeking a Quality Associate I to ensure the highest standards of product quality and regulatory compliance. This role involves maintaining quality oversight of manufacturing areas, reviewing records, and collaborating with teams to ensure operational excellence.

Successful candidates will have a background in Pharmaceutical Quality and relevant software proficiency. The position also offers comprehensive benefits and a commitment to professional growth.

Qualifications

• Bachelor's degree preferred; or Associate’s with experience.
• At least 1 year in Pharmaceutical Quality or 2 years without degree.
• Proficiency in computer software for manufacturing environments.

Responsibilities

• Ensure compliance with all regulatory agency requirements.
• Review records for compliance with cGMP requirements.
• Report errors and deficiencies to management.
• Perform quality functions in classified areas.
• Assist with internal and external audit preparations.
• Initiate Nonconformance Reports and corrective actions.
• Conduct bi-annual inspections of classified areas.
• Revise standard operating procedures as needed.

Skills

Microsoft Word

Microsoft Excel

Microsoft Outlook

Education

Bachelor’s degree in science discipline

Associate’s degree with 1 year of experience

2 years experience in regulated industry

Tools

JDE

SAP

Maximo

TrackWise

Job description

Simtra BioPharma Solutions in Bloomington, Indiana is seeking a Quality Associate I to ensure the highest standards of product quality and regulatory compliance. This role involves maintaining quality oversight of manufacturing areas, reviewing records, and collaborating with teams to ensure operational excellence.

Successful candidates will have a background in Pharmaceutical Quality and relevant software proficiency. The position also offers comprehensive benefits and a commitment to professional growth.