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IQC Technician

INCOG is looking for an Incoming Quality Control (IQC) Technician that has a passion for working within a team, a desire to drive Quality processes, and an eagerness to ensure Operations readiness from a Quality perspective. The IQC Technician will report to INCOG’s IQC Supervisor and work closely with Supply Chain, Quality Control and Operations to support readiness of materials for manufacture of sterile, injectable products. The IQC Technician will perform routine sampling for components, API, BDS, and excipients undergoing QC testing, perform routine analytical techniques related to material testing and component inspection, and manage day-to-day tasks within the Incoming Quality Control laboratory including but not limited to: consumables ordering, daily instrument calibration/verification, laboratory waste management, laboratory/equipment cleaning, and sample shipment coordination to outside laboratories. The IQC Technician will be crucial in helping INCOG maintain efficient operational readiness by supporting our Quality Mindset with skills including attention to detail, on-time delivery, and commitment to Quality excellence. 
 
Excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences is critical in this role. The IQC Technician will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, clients, suppliers, and partners. The IQC Technician will thrive in a team environment but can also work autonomously with strong self-management and organizational skills.  
 
Essential Job Functions: 
 
Interpersonal Focus 
  • Be team oriented and act as a contributor to special projects when needed.  
  • Sets deadlines and prioritizes work for self, group members, and support groups involved.  Reviews work performed by coworkers for accuracy and alignment with procedures. 
  • Collaborates with internal departments and teams to resolve quality issues regarding materials needed for Operational campaigns. 
  • Understands urgency and acts accordingly regarding turnaround times and release coordination.  
Technical Focus 
  • Samples and inspects incoming materials. 
  • Performs component visual inspection and dimensional analysis. 
  • Performs instrument verifications as needed. 
  • Generates/Reviews Certificates of Analyses (COA’s) for materials release from IQC testing  
  • Performs peer data review as needed. 
  • Performs ordering of required outside testing and coordinates shipment of samples to outside laboratories. 
 
Competencies 
  • Demonstrates excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. 
  • Thrives in a team environment but can work autonomously with strong self-management and organizational skills. 
  • Commits to a culture of quality with skills including attention to detail, on time delivery, and efficiency. 
  • Upholds customer-centric mindset. 
 
Special Job Requirements: 
  • Associate’s Degree (Science discipline preferred) or High School Degree and minimum two (2) years’ experience within the pharmaceutical/biopharmaceutical industry in Quality Control. 
  • Strong math and documentation skills. 
  • Strong oral and written communication and interpersonal interaction skills.  
  • Ability to work in a highly regulated environment. 
  • Ability to lift up to 50 lbs.  
  • Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, QMS, etc.). 
 
Additional Preferences: 
  • Experience with statistical material sampling. 
  • Experience within the pharmaceutical/biopharmaceutical industry-sterile manufacturing. 
  • Experience reading and interpreting compendial test methods (USP/EP/JP specifically). 
  • Experience in Quality Assurance/Quality Control. 
 
Additional info about INCOG BioPharma Services: 
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.  
 
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. 
 
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. 
 
By submitting your resume and details, you are declaring that the information is correct and accurate. 

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What You Should Know About IQC Technician, INCOG BioPharma Services

INCOG is excited to announce an opening for an Incoming Quality Control (IQC) Technician who is ready to dive into the world of pharmaceutical manufacturing. If you have a passion for teamwork, a knack for driving quality processes, and a relentless desire to ensure materials are ready for production, this could be the perfect opportunity for you! Reporting to the IQC Supervisor, you'll partner closely with our Supply Chain, Quality Control, and Operations teams to support the meticulous readiness of materials required for sterile injectable products. Your day-to-day role will involve conducting routine sampling and inspecting incoming components, as well as testing APIs, BDS, and excipients. You’ll manage tasks in the Incoming Quality Control laboratory, including ordering consumables, instrument calibration, and sample shipment coordination. We’re looking for someone who exemplifies a commitment to quality and demonstrates keen attention to detail and timely delivery. You will need excellent communication skills since articulating complex issues clearly is crucial in this role. By building collaborative relationships with colleagues and suppliers while also thriving in a team environment, you will play an essential role in sustaining INCOG’s dedication to operational excellence. If you’re someone who loves to both collaborate and work independently, has an eye for detail, and possesses strong self-management skills, we’d love to see you bring your talents to INCOG BioPharma. Let’s work together to ensure top-notch quality in our products!

Frequently Asked Questions (FAQs) for IQC Technician Role at INCOG BioPharma Services
What responsibilities does the IQC Technician at INCOG involve?

The IQC Technician at INCOG is responsible for sampling and inspecting incoming materials, conducting routine analytical techniques related to material testing, and managing laboratory tasks such as consumables ordering and daily instrument calibration. They'll also play a pivotal role in ensuring operational readiness for sterile products.

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What qualifications are required for the IQC Technician role at INCOG?

The IQC Technician position at INCOG requires an Associate’s Degree in a science discipline or a high school diploma coupled with a minimum of two years' experience in Quality Control within the pharmaceutical or biopharmaceutical industry. Strong math skills and the ability to work in a highly regulated environment are also essential.

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How does the IQC Technician at INCOG ensure quality excellence?

The IQC Technician at INCOG ensures quality excellence by performing thorough inspections and tests on incoming materials, reviewing Certificates of Analyses, and collaborating closely with various departments to resolve any quality issues promptly and efficiently.

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What skills are essential for an IQC Technician at INCOG?

Essential skills for the IQC Technician at INCOG include strong attention to detail, excellent written and oral communication abilities, and the capacity to work both in a team and independently, all while maintaining a commitment to quality and efficiency.

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What is the team culture like for the IQC Technician at INCOG?

INCOG promotes a collaborative and team-oriented culture, where the IQC Technician can thrive while also developing strong, customer-centric relationships with colleagues and suppliers. The team works together toward a common goal of operational readiness and quality assurance.

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What type of experience is preferred for the IQC Technician position at INCOG?

Preferred experience for the IQC Technician role at INCOG includes familiarity with statistical material sampling, knowledge of sterile manufacturing in the pharmaceutical or biopharmaceutical industry, and the ability to interpret compendial test methods such as USP/EP/JP.

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How does the IQC Technician contribute to INCOG’s mission?

The IQC Technician contributes to INCOG’s mission by ensuring that quality standards are upheld throughout the manufacturing process, supporting operational readiness, and helping deliver exceptional quality outcomes that accelerate customer routes to market.

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Common Interview Questions for IQC Technician
What experience do you have with incoming material inspections as an IQC Technician?

When discussing your experience with incoming material inspections, be specific about the types of materials you've inspected, the standards you followed, and any relevant quality control measures you implemented. Highlight any technical skills related to visual inspection or dimensional analysis.

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How do you prioritize tasks in a busy lab environment as an IQC Technician?

Explain your method for prioritizing tasks such as using a to-do list or collaborating with team members. Share an example of a time when you had to manage multiple deadlines and how you ensured timely completion of high-quality work under pressure.

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Can you describe a time you resolved a quality issue in your previous role?

Select a relevant example where you identified a quality issue, took steps to resolve it, and collaborated with colleagues to prevent it from recurring. Emphasize your problem-solving skills and commitment to quality excellence.

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What analytical techniques are you familiar with in quality control?

Discuss any analytical techniques you have experience with such as chromatography, spectrometry, or statistical sampling methods. Highlight how these techniques were employed in your past roles to ensure the quality of incoming materials.

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How do you ensure accuracy when generating Certificates of Analyses?

Ensure to mention your attention to detail and any specific processes you follow to verify the accuracy of Certificates of Analyses. Discuss double-checking data, collaborating with team members, or using quality management systems to prevent errors.

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What strategies do you use for effective communication within a team?

Mention your approach to keeping communication open and clear within a team. This can include regular check-ins, collaborative meetings, and utilizing digital tools. Share a positive outcome that resulted from effective communication.

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What role does documentation play in your work as an IQC Technician?

Documentation is critical in quality control; highlight your experience in maintaining accurate lab records and compliance with regulatory requirements. Discuss how thorough documentation aids in tracking materials and ensuring quality standards are met.

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How do you adapt to changes in a highly regulated environment?

Discuss your adaptability and willingness to learn new regulations as they arise. Provide an example of a situation where you effectively adjusted to changes in protocols while maintaining high-quality outputs.

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What motivates you to pursue a career as an IQC Technician?

Share your passion for quality assurance, detail the satisfaction you derive from ensuring high-quality outcomes, and discuss how the supportive culture at INCOG aligns with your career goals and values.

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Can you explain how you would handle a situation where outcomes deviate from expected quality standards?

Outline the steps you would take to assess the issue, communicate with stakeholders, and implement corrective actions. Highlight your focus on resolution and continuous improvement within quality processes.

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INCOG BioPharma Services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges. In addition, they offer customized packaging services t...

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Full-time, on-site
DATE POSTED
November 28, 2024

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