What are the responsibilities and job description for the Principal Associate – QC Laboratory Data Reviewer position at Eli Lilly and Company?
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.
The Principal Associate – QC Laboratory Data Reviewer performs accurate and timely review of laboratory data, in accordance with appropriate GMP and safety guidelines, to support site production and stability requirements. The QC Laboratory Data Reviewer will be responsible for complying with company and regulatory requirements. The Principal Associate – QC Laboratory Data Reviewer will perform data review for laboratory test results including, but not limited to, UV-VIS, HPLC, Capillary Electrophoresis (CE), device testing. Turbidity, osmolality, TOC, pH, Conductivity, and wet chemistry testing. The Principal Associate – QC Laboratory Data Reviewer will author investigations, change controls and CAPA and will be a member of the laboratory compliance team. Additionally, the QC Laboratory Data Reviewer will be required to support inspection readiness activities as will be responsible for maintaining compliance with all company and regulatory requirements. The Principal Associate – QC Laboratory Data Reviewer will engage in laboratory safety and continuous improvement initiates on a routine basis. The QC Laboratory Data Reviewer utilizes technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and assist in resolving laboratory investigations of atypical data and results. The Principal Associate – QC Laboratory Data Reviewer may also be required to perform Chemistry and device testing at times to support business needs. Testing would include, but not be limited to HPLC, UV-Vis, Capillary Electrophoresis, device testing, compendia testing.
Key Objectives and Deliverables
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
$63,000 - $162,800
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
The Principal Associate – QC Laboratory Data Reviewer performs accurate and timely review of laboratory data, in accordance with appropriate GMP and safety guidelines, to support site production and stability requirements. The QC Laboratory Data Reviewer will be responsible for complying with company and regulatory requirements. The Principal Associate – QC Laboratory Data Reviewer will perform data review for laboratory test results including, but not limited to, UV-VIS, HPLC, Capillary Electrophoresis (CE), device testing. Turbidity, osmolality, TOC, pH, Conductivity, and wet chemistry testing. The Principal Associate – QC Laboratory Data Reviewer will author investigations, change controls and CAPA and will be a member of the laboratory compliance team. Additionally, the QC Laboratory Data Reviewer will be required to support inspection readiness activities as will be responsible for maintaining compliance with all company and regulatory requirements. The Principal Associate – QC Laboratory Data Reviewer will engage in laboratory safety and continuous improvement initiates on a routine basis. The QC Laboratory Data Reviewer utilizes technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and assist in resolving laboratory investigations of atypical data and results. The Principal Associate – QC Laboratory Data Reviewer may also be required to perform Chemistry and device testing at times to support business needs. Testing would include, but not be limited to HPLC, UV-Vis, Capillary Electrophoresis, device testing, compendia testing.
Key Objectives and Deliverables
- Review analytical data generated by other analysts within the lab as required.
- Adhere to all Environmental, Health, and Safety standards.
- Understand the scientific principles required for testing of drug substances and drug product, including the interaction of the chemistry and lab equipment.
- Provide technical support for non-routine (e.g., deviation) investigations.
- Strong understanding of FDA guidelines, Compendial and cGMP requirements.
- Recognizes deviations from procedures, methods, etc., and initiates investigations as required.
- Recommend CAPAs for laboratory investigations.
- Bachelor (4-year college) degree in Chemistry, Biology or Microbiology and Relevant experience in a pharmaceutical chemistry lab.
- Experience with a LIMS (Laboratory Information Management System) system and Empower®.
- Trackwise® experience (change controls, Investigations, Activity Planning).
- Laboratory experience with HPLC and CE instruments and Testing.
- Previous experience testing by compendia methods.
- Demonstrated problem solving and analytical thinking skills.
- Understanding of statistical tools and trend analysis.
- Excellent interpersonal skills and networking skills.
- Strong self-management and organizational skills.
- Experience in a GMP QC lab environment.
- Demonstrated written and verbal communications skills.
- Strong attention to detail.
- Ability to organize and prioritize multiple tasks.
- Experience with Root Cause Analysis (fishbone, 5 why’s, Causal Factor, Fault Tree analysis).
- May be required to provide on call support.
- Demonstrated ability to work both independently and as a part of a Team.
- Applicant will initially work 8-hour day shift Monday through Friday (8:00 am to 5:00 pm) for 3 months, then transition to 10-hour day shift – Wednesday through Saturday (8:00 am to 7:00 pm).
- May require support outside of regular schedule in support of continuous (24/7) manufacturing operations.
- Applicant will work in various areas within the site. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
- Tasks may require repetitive motion (e.g., keyboarding).
- Minimal travel required.
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
$63,000 - $162,800
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
Salary : $63,000 - $162,800
