Simtra BioPharma Solutions-posted 10 months ago
Full-time
Bloomington, IN

The Inspector Operator works within the Finishing/Packaging Complex. They visually inspect (manually and semi-automated) product containers, closures and contents for defects according to standard operating procedures (SOP). They are detail oriented, adhere to guidelines, and achieve goals in order to meet client demand. This role contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. This position reports to the Finishing Supervisor.

  • Manually visually inspect product in black & white booth or semi-automated inspection machine at established target rates or qualified speeds, respectively
  • Organize and segregate rejects according to category of defect
  • Count and or verify proper unit count; reconcile to count received
  • Document all current Good Manufacturing Practices (cGMP) activities at the time of performance and as required in the Batch Record or controlled forms
  • Provide support and feedback to manufacturing team to reduce/eliminate controllable defects
  • Assist with the inspection of performance qualification/validation materials, Technical Services studies, and larger scale sampling operations
  • Inspect and document results from Knapp study sample sets for validation use; provide support for results summary
  • Contribute to the inspection library when 'new' defects or limit samples are discovered
  • Identify, communicate and solve problems to ensure quality, efficiency, and safety objectives are met
  • Set-up, Tear down, and Clear Inspection area
  • Participate/perform line clearance activities
  • Dispose of rejects in the appropriate disposal area following reconciliation or box rejects to return to client
  • Stage materials in the appropriate designated locations
  • Prepare paperwork for upcoming inspection(s)
  • Coordinate material on-time material delivery and pick-up with internal and external warehouse personnel
  • Track/document Time out of Refrigeration (TOR) upon movement of product to and from controlled storage so as not to exceed specified limits
  • Required to maintain attendance in accordance with the Bloomington Attendance Policy
  • High School diploma or GED required
  • 6 months of previous Pharmaceutical or Manufacturing experience preferred
  • Visual acuity 20/20 with or without corrective vision and ability to pass color blind test
  • Ability to work independently
  • Good communication skills
  • Good documentation skills, including legible handwriting
  • Good interpersonal skills
  • Basic computer skills
  • Basic math skills
  • Knowledge of standard operating procedures, specifications, and job-specific training materials
  • Requires the operations of handheld light meters and basic packaging materials such as pallet wrappers and tape guns
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life Insurance
  • Short and Long-Term Disability 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
  • Vision Coverage
  • Accident Insurance
  • Critical Illness Insurance
  • Hospital Indemnity Insurance
  • Identity Theft Protection
  • Legal Insurance
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