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QC Biochemist/Microbiologist

Company: Lilly
Location: Durham
Posted on: November 22, 2021

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 35,000 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.

Company Overview:

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 39,000 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. #WeAreLilly

Position Brand Description:

The QC Biochemist/Microbiologist reviews, interprets, and releases batch results for the laboratory. This person leads the design and execution of method development and validations, technology transfers, and equipment evaluation and qualification. They may perform non-routine lab work in support of those projects. They utilize their technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations of aberrant data and results.-Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented by the QC Biochemist/Microbiologist and may be published in regulatory and/or technical documents. The position is responsible for technical mentoring of lab staff and sharing technical information and best practice within the work group and across plant sites. This individual participates and influences the design and installation of systems, procedures, and methods for the startup of the QC biological testing and environmental monitoring labs at the site.

Key Objectives/Deliverables:

  • Technical review, interpretation and release of data.
  • Contributes to annual product reviews and process validations as required.
  • Interacts effectively with business partners to communicate and resolve issues and gain a clear and accurate understanding of each other's requirements.
  • Perform technical training.
  • Coach lab analysts in real time.
  • Mentor analysts through formal process/program
  • Review and approve change controls and deviations.
  • Review and interpret data and document results of analyses and conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines. Writes and publishes regulatory and/or technical reports and memos.
  • Utilizes technical skills to lead or perform in-depth investigations into out of spec results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
  • Develop investigational testing protocols and perform testing as required.
  • Method verification/transfer/validation/remediation.
  • Monitor method and process performance.
  • Research and recommend new technologies.
  • Improve lab quality systems; develop content, review, and approve SOPs and training as necessary.
  • Contribute to development and implementation of Global Lab Quality Standards.
  • Comply with and implement safety standards.
  • Provide technical oversight for Periodic Management Reviews.
  • Communicate effectively in both written and oral formats within the lab as well as with external customers and business partners.
  • Types of communication include:
  • Notification to management of quality issues
  • Interaction with other functions and auditors
  • Participation in internal/external audits.

    Minimum Requirements:
  • Demonstrated accuracy and proficiency in analytical skills.
  • Demonstrated strong problem-solving skills. Preferred training and demonstrated proficiency in Root Cause Analysis methodology.
  • Strong oral and written communication skills and demonstrated through documentation and presentation skills.
  • Demonstrated strong interpersonal interaction skills.
  • Ability to focus on continuous improvement.
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

    Additional Preferences:
  • Demonstrated proficiency in laboratory analysis including, but not limited to endotoxin, bioburden, sterility, non-viable and viable particulates, and colony identification.
  • Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
  • Deep understanding of compliance requirements and regulatory expectations.

    Education Requirements:
  • Bachelor's degree in Biology, Chemistry, or a similar science field and 7+ years of demonstrated relevant experience in a GMP lab.

    Other Information:
  • Tasks may require repetitive motion and standing for long periods of time
  • 8 hour days - Monday through Friday
  • Occasional shift work when required within the lab
  • Required to be available off shift and respond to operational issues.
  • Minimal travel required.

    The job specification is intended to provide a general overview of the job requirements at the time it was prepared.- The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.-

    Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

    Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Keywords: Lilly, Durham , QC Biochemist/Microbiologist, Other , Durham, North Carolina

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