Inspection Operator (1st Shift)

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 and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

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 – 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 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.

The 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/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
• 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

The 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:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions:

• 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 for Inspection Operator 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 requirement(s):

• 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 in order to comply with necessary SOP', job-specific training materials, GMP's, and other manuals.

In return, you'll be eligible for[1]:

• Day One Benefits
  • 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 and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • 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 12/31/24

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 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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