Technician- QC- API

Initial Therapeutics, Inc.; Lebanon (IN); On-site; Full time

Job summary

A leading healthcare company in Indiana is seeking a Technician - QC - API to conduct testing and analysis in a GMP lab environment. The role involves ensuring quality compliance, testing various materials, and supporting continuous improvement initiatives. Ideal candidates will have a degree in Biotechnology and strong analytical skills.

Benefits

401(k) plan

Medical, dental, vision benefits

Pension plan

Paid time off

Flexible benefits

Qualifications

• Experience in a regulated lab environment required.
• Proficiency in Microsoft Office products.
• Understanding of cGMPs and environmental monitoring procedures.

Responsibilities

• Conduct collection and testing of GMP laboratory samples.
• Perform analysis for In-process support and environmental monitoring.
• Ensure compliance with current Good Manufacturing Practices (cGMPs).

Skills

Attention to detail

Critical thinking

Troubleshooting skills

Communication skills

Education

Associates degree in Biotechnology

Tools

Computer systems

Electronic systems

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Description: The Technician - QC - API conducts collection and precise/prompt testing of GMP laboratory samples. This role may include performing analysis for In-process support, environmental monitoring, as well as testing compressed air and nitrogen for all API buildings. Responsibilities involve ensuring adherence to current Good Manufacturing Practices (cGMPs), carrying out second person verification (SPV) of analytical data, assisting in laboratory investigations, and performing equipment calibrations and maintenance in accordance with established protocols and procedures. Additionally, the technician identifies and communicates potential improvements within the lab by adhering to Lilly CCI/Lean standards and ensures that monitoring frequencies comply with procedural requirements.

Key Objectives/Deliverables:

Sample Analysis and Reporting:

• Accurately and safely perform analytical test methods or related support activities as per procedures or protocols.
• Review analytical data to ensure that results conform to standards.
• Perform data entry and review own work for accuracy in accordance with laboratory procedures, standards, and GMP requirements.
• Recognize deviations from procedures and initiate investigations.
• Verify (SPV) analytical data of other analysts within the lab as required.
• Ensure complete and effective monitoring data using electronic systems or paper documents.
• Support other areas with Environmental Monitoring, perform environmental monitoring sampling, including non-viable, viable, surface sampling, and personnel monitoring. Participate in Environmental Monitoring Performance Qualification (EMPQ) execution.
• Support a constant state of inspection-readiness.

Continuous Improvement Initiatives:

• Identify and communicate opportunities for improvement initiatives in daily work activities.
• Follow Lilly standards for CCI/Lean and support departmental or site continuous improvement initiatives.

Lab Operations:

• Train and mentor others within the lab.
• Execute notifications to management when required by procedures or standards.
• Perform routine equipment qualifications/calibrations or maintenance through execution of well-defined protocols. (where applicable)
• Troubleshoot equipment and methods as required. (where applicable)
• Participate in laboratory investigations. Provide support for analytical method transfer as necessary. (where applicable)

Safety and Compliance:

• Ensure compliance with cGMPs and assist in the identification and investigation of non-conformance issues.
• Maintain a safe work environment, work safely, and support all HSE Corporate and Site Goals.

Basic Requirements:

• Associates degree in Biotechnology, including dedicated laboratory training and experience.

Additional Preferences:

• Ability to work in a highly regulated environment lab environment, including wearing appropriate PPE and using other safety-required equipment.
• Understanding of cGMPs, environmental monitoring procedures, processes, and equipment.
• Excellent written and oral communication skills, troubleshooting and investigative skills, and critical thinking and decision-making skills.
• High-quality skills, including attention to detail and the capability of meeting critical deadlines by organizing and prioritizing multiple tasks.
• Proficiency with computer systems, including instrument-specific applications and Microsoft Office products.
• Strong math and documentation skills and basic understanding of basic statistical tools

• Previous Continuous Improvement or Operational Excellence experience or certifications.

Other Information:

• Ability to obtain and maintain aseptic gown certification.
• Role may be in support of 24-hour operations, requiring shifts that cover days, nights, and weekends.
• Overtime as needed and must be available off-shift to respond to operational issues.
• Tasks may require repetitive motion and standing for long periods of time.
• Must be able to lift at least 25 pounds.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$17.30 - $39.06

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly