Sr. QA Inspector - Label Control (2nd Shift)

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. 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. Our product types include biologics, small molecules, cytotoxics, highly potent compounds, diluents for reconstitution, and vaccines.

The Sr. Quality Inspector (Label Control) is a member of the Finishing Quality Assurance Team reporting directly to the Quality Finishing Line Operations Supervisor. They are responsible for printing, counting, inspecting, and issuing all client-specific printed materials for pharmaceutical products. This role ensures meeting client demand with first-pass quality using controlled documentation and current Good Manufacturing Practices (cGMP) guidelines. Additionally, the role involves ensuring accuracy of inventory counts and providing training for new Label Control employees.

Responsibilities

• Calculate quantity of each Printed Material required for each batch
• Set up print jobs and ensure accuracy of all in-house Printed Material
• Assemble all required Printed Materials and imprint devices for each batch as directed by the Finishing Specification Sheet
• Document, issue, and release all Printed Materials
• Return Printed Materials to inventory as appropriate
• Perform resupplies of materials
• Clearance of print stations
• Ensure organization and maintenance of the Label Control Cage
• Participate in process improvement teams for Label Control activities
• Act as the first point of contact for any printed materials/Label Control issues that occur
• Perform inventory cycle counts in the enterprise resource planning system
• Perform QA Checklist Assessments to ensure compliance of all areas in the Finishing department
• Cross-train on the basic job skills for both QA Finishing Line Operations and the QA Warehouse Technician (including line clearance, AQL inspection, and Reserve Sample Inspection)

Requirements

• High School diploma or GED required
• Minimum 2 years experience in a pharmaceutical or biotech industry required
• General knowledge of Quality and Warehouse Operations is preferred
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, ROBAR, etc.)

Physical / Safety Requirements

• Must be able to lift 50 lbs
• Must be able to qualify to 20/20 corrected vision and pass color blindness testing
• Must be able to perform physical tasks which include bending, twisting, kneeling, and stooping
• Must be able to sit and stand for extended periods of time
• Must wear appropriate personal protective equipment, as applicable
• Duties may require overtime work, including nights, weekends, and holidays
• Use of hands and fingers to manipulate office equipment is required

Schedule

Monday-Friday, 2:45 PM - 11:15 PM

Benefits

• 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
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
• Vision Coverage
• Accident Insurance
• Critical Illness Insurance
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal Services
• Onsite Campus Amenities:
  • Workout Facility
  • Cafeteria
  • Credit Union