Quality Associate - Filling; 2nd shift

Job Overview

The Quality Associate I is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Line Operations Lead. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Simtra Standard Operating Procedures.

This position strives for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. This position is 6:30 am-3:30 pm and is onsite at the Bloomington facility.

• Ensures compliance with all worldwide regulatory agency requirements and company-specific regulations related to quality of product and employee safety.
• In-process review of records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. Records include batch records and other documents involved in the aseptic processing of drug product.
• Reports errors, deficiencies, discrepancies and observations to management. 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. 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, Pharmaceutical Manufacturing or other GXP regulated industry experience, or no degree with at least 2 years Pharmaceutical Quality, Pharmaceutical 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.

• Day One Benefits
  • 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

[1] Current benefit offerings are in effect through 12/31/26

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

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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