Incoming Quality Control Technician

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

Your role at Simtra BioPharma Solutions:

The Incoming Quality Control Technician plays a vital role in the safety of patients and overall success of the manufacturing process by inspecting the incoming products and raw materials under the supervision of the Quality Lead.

The working hours for this role are Monday-Friday 7:00am-3:30pm.

What you’ll do:

• Perform a variety of physical, functional testing, and inspection analysis on components that support the company’s quality manufacturing program

• Sample raw material and components for inspection, QC analysis, and sample requests

• Perform raw material verification on incoming material used in production

• Operate and maintain a variety of laboratory equipment

• Maintain a good attendance record

• Perform existing procedures with recommendations for improved efficiency

• Write, review, and revise SOP’s when needed. Write coherent and complete reports

• Maintain an accurate and up-to-date training history

• Train others on skills required

• Act as a role model for the laboratory

• Strong team player and willingness to help others

• Ability to work independently with minimal supervision

What you’ll bring:

• A High School Diploma or GED equivalent

• Previous QC and/or QA experience preferred

• Excellent Documentation Skills

• Excellent Communication Skills

• Computer Skills including word and excel

• Organizational and Detail Oriented skills

Physical / Safety Requirements

• Must wear appropriate PPE as required for various manufacturing areas when applicable.

• Must be able to gown qualify for Grade A/B areas when applicable.

• 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.

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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.

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