Inspection Operator - Shift 3

Simtrabps; Bloomington (IN); On-site; USD 30,000 - 45,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Flexible Spending Accounts

Paid Time Off

Education Assistance Program

Employee Assistance Program

Job summary

Simtrabps is seeking an Inspector Operator to join their team in Bloomington, Indiana. The role involves visually inspecting product containers and adhering to strict quality guidelines in a controlled pharmaceutical environment.

The ideal candidate will have a high school diploma or GED, and good communication and documentation skills. The position offers benefits from day one including medical coverage and a 401(k) retirement plan.

Qualifications

• Must have a high school diploma or GED.
• Requires 6 months of previous pharmaceutical or manufacturing experience.
• Ability to understand, speak, read, and write English.

Responsibilities

• Visually inspect product containers for defects.
• Document all current Good Manufacturing Practices (cGMP) activities.
• Organize and segregate rejects according to category of defect.

Skills

Attention to detail

Good communication skills

Basic math skills

Good documentation skills

Ability to work independently

Education

High School diploma or GED

Job description

Simtra BioPharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring 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 and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – all directly injected into patients worldwide. There is a strong emphasis on quality and continuous improvement, holding ourselves to the highest quality and regulatory standards.

Why join Team Simtra?

Make it HAPPEN – we bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – we work as one, respecting each voice and tapping into our unique strengths across teams so we can solve problems in new ways. Make it RIGHT – we hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – we take pride in our day‑to‑day work, knowing the impact we make and taking on challenges big and small to improve patient health.

This role

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 an environment where teamwork, productivity, safety, identity, strength, purity and quality are reflected in the finished product. This position reports to the Finishing Supervisor.

Shift 3: 10:45 PM – 6:45 AM

Responsibilities

• 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 or 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 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
• Maintain attendance in accordance with the Bloomington Attendance Policy
• Work schedule M‑F, 10 hours per day with additional overtime as required
• Visual acuity 20/20 with or without corrective vision and ability to pass color‑blind test
• Ensure all safety practices are followed and keep area clean and clear of hazards

Work environment

Controlled pharmaceutical environment including wearing long sleeves, safety toe shoes, gloves and safety glasses. Ability to work on a focused task independently for specific durations of time.

Desirable qualifications

• 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

Physical / safety requirements

• Occasional (0‑33%) – Walking, climbing stairs and ladders, reaching overhead, balancing, kneeling, crouching, crawling; lifting up to 38 lbs; carrying 30 lbs
• Frequent (34‑66%) – Sitting, standing, reaching forward, object handling, fingering, fine hand coordination, simple and firm hand grasping, operating controls; lifting and carrying up to 32 lbs; pushing and pulling up to 16 lbs
• Constant (67‑100%) – Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping
• Final candidates will be required to pass a post‑offer/pre‑employment job placement examination which will test the physical capabilities to perform the essential functions of the job

Additional requirements

• Education and experience: High School diploma or GED required; 6 months of previous pharmaceutical or manufacturing experience preferred.
• Language skills: must be able to understand, speak, read and write English to comply with necessary SOP, job‑specific training materials, GMP’s, and other manuals.

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 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

Current benefit offerings are in effect through 12/31/26.

Disclaimer

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.

Equal Employment Opportunity

Simtra is 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.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy: Privacy Policy — Simtra BioPharma Solutions