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Assoc Conslt-QA

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Job Summary

Company
Lilly
Location
Indianapolis, IN 46201
Industries
Biotechnology/Pharmaceuticals
Job Type
Full Time
Employee
Years of Experience
2+ to 5 Years
Education Level
Bachelor's Degree
Career Level
Experienced (Non-Manager)
Job Reference Code
11508BR

Assoc Conslt-QA

About the Job

Company Description

Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees – in competitive salaries, training and development, and health.

The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.

If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.


Responsibilities:

The Engineer – QA provides support to Parenteral Products production, while maintaining quality systems and GMP compliance. The Engineer - QA provides primary support to Facility/Utilities/HVAC process teams and the IT functional group, providing assistance and guidance in non-conformance investigations, design, construction, equipment and computer systems, change control proposals, procedure revisions, GMP drawings, validations, and commissioning and qualification. The Engineer – QA’s position is essential for maintaining GMP compliance and in the preparation for pre-approval and general inspections by various regulatory agencies.

 

Basic Qualifications:
  • Bachelor of Science Degree in Engineering or equivalent experience.
  • Qualified candidate must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.

 

Additional Skills/Preferences:

  • Previous experience with Lilly deviation and change control process
  • Experience in Production, Engineering, QC, QA, or Technical Services is desirable.
  • Knowledge of cGMP's
  • Demonstrated technical writing and written communication skills
  • Demonstrated relevant experience in a GMP facility
  • Become/remain certified on CSV (Computer System Validation)
  • Proficient with computer systems including Microsoft Office, EDMS, Trackwise, SAP, etc
  • Demonstrated strong communication and interpersonal interaction skills
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

 

Additional Information:

  • Overtime may be required.
  • May be required to support off shift activities related to operational issues.
  • Applicant may work in various areas within the Parenteral Plant.
  • Some allergens are present in the Parenteral Plant.
  • Mobility requirements and exposure to allergens should be considered when applying for this position.
  • May be subject to Post Offer Exam

 

Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status

 

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