Quality Associate - Filling; 3rd Shift

Quality Associate I - Filling (3rd Shift)

Bloomington, Indiana, United States

Simtra Bio Pharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization that specializes in cGMP manufacturing of sterile injectable products. The Quality Associate I focuses on maintaining quality oversight of manufacturing areas, ensuring compliance with regulatory standards, and driving continuous improvement.

The Quality Associate I is a member of the Quality Assurance Line Operations Team, reporting directly to the Quality Line Operations Lead. The role involves working closely with manufacturing personnel to perform checks during manufacturing processes and assessing regulatory and quality risks according to agency rules, guidelines, and Simtra Standard Operating Procedures.

• Ensures compliance with all worldwide regulatory agency requirements and company‑specific regulations related to product quality and employee safety.
• Conducts in‑process review of records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements, including batch records and other documents involved in aseptic processing of drug product.
• Reports errors, deficiencies, discrepancies and observations to management and may stop operations when product safety is or may be compromised.
• Performs quality functions in classified areas, including production oversight, manufacturing process assessments, and aseptic intervention oversight.
• Works in collaboration with management teams to prepare for internal and external audits and assists with timely closure of audit observations and CAPAs.
• Initiates and authors Nonconformance Reports and corrective and preventative action responses.
• Conducts bi‑annual inspections of classified areas in preparation for facility shutdown periods.
• Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement.
• Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.

• Bachelor’s degree (preferred science discipline), or Associate’s degree with at least 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 2 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience.
• Computer proficiency in Microsoft Word, Excel, and Outlook, and the ability to use enterprise software (examples include JDE, SAP, Maximo, Track Wise, etc.).

• Must wear appropriate PPE as required for various manufacturing areas.
• Must be able to gown qualify for Grade A/B areas.
• Duties will require overtime work, including scheduled weekend shifts.
• Use of hands and fingers to manipulate office equipment is required.
• Position requires standing for long hours, but may require sitting for periods of time.

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Additional Benefits
  • Short and Long‑Term Disability Insurance
• 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

Simtra is proud to be an equal opportunity employer. We evaluate 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. EEO is the law.