Quality Control Technician-Environmental Monitoring (Night Shift)
Eli Lilly and Company
7 months ago
On-site
Durham, NC
Operations
Responsibilities:
- Support production operations by EM sampling of classified manufacturing, filling, support areas, and operations personnel.
- Support daily EM laboratory operations and process/equipment qualification activities, as necessary.
- Ensure compliance with cGMP and maintain constant inspection-readiness.
- Ensure data integrity is maintained; participate in process streamlining and continuous performance improvement.
- Maintain a safe work environment, working safely and supporting all HSE Corporate and Site Goals; maintain gowning certification and repeatedly aseptically gown daily.
Basic Requirements / Qualifications:
- High School Diploma or equivalent; Associate degree preferred.
- Environmental Monitoring experience preferred; manufacturing/production experience preferred.
- Experience in aseptic manufacturing/production, QC/QA, Technical Services, or Regulatory desirable.
- Technical writing and written communication skills a plus.
- Understanding of regulatory standards/requirements for EM; familiarity with parenteral production environments and operations.
- Strong computer skills, documentation skills, and attention to detail.
- Ability to focus on continuous improvement.
- Previous lab IT systems experience including LIMS, LES, and standalone COTS systems.
- Understanding of compliance requirements and regulatory expectations for lab systems.
- Understanding of cGMP; excellent written and oral communication; ability to collaborate and interact with a team.
- Ability to work in a dynamic, fast-paced environment; potential to work shifts and weekends.
Additional Information:
- Must lift 30 pounds; must be able to pass, push, and pull; stand/walk for extended periods.
- Minimal travel required; some allergens present in the parenteral plant.
- Schedule: starts on days before transitioning to night shift; 12-hour shifts on 2-2-3 schedule (6PM–6AM).
Application instructions / authorization:
- Full-time work authorization in the United States required; Lilly will not sponsor work authorization or visas for this role.
- Support production operations by EM sampling of classified manufacturing, filling, support areas, and operations personnel.
- Support daily EM laboratory operations and process/equipment qualification activities, as necessary.
- Ensure compliance with cGMP and maintain constant inspection-readiness.
- Ensure data integrity is maintained; participate in process streamlining and continuous performance improvement.
- Maintain a safe work environment, working safely and supporting all HSE Corporate and Site Goals; maintain gowning certification and repeatedly aseptically gown daily.
Basic Requirements / Qualifications:
- High School Diploma or equivalent; Associate degree preferred.
- Environmental Monitoring experience preferred; manufacturing/production experience preferred.
- Experience in aseptic manufacturing/production, QC/QA, Technical Services, or Regulatory desirable.
- Technical writing and written communication skills a plus.
- Understanding of regulatory standards/requirements for EM; familiarity with parenteral production environments and operations.
- Strong computer skills, documentation skills, and attention to detail.
- Ability to focus on continuous improvement.
- Previous lab IT systems experience including LIMS, LES, and standalone COTS systems.
- Understanding of compliance requirements and regulatory expectations for lab systems.
- Understanding of cGMP; excellent written and oral communication; ability to collaborate and interact with a team.
- Ability to work in a dynamic, fast-paced environment; potential to work shifts and weekends.
Additional Information:
- Must lift 30 pounds; must be able to pass, push, and pull; stand/walk for extended periods.
- Minimal travel required; some allergens present in the parenteral plant.
- Schedule: starts on days before transitioning to night shift; 12-hour shifts on 2-2-3 schedule (6PM–6AM).
Application instructions / authorization:
- Full-time work authorization in the United States required; Lilly will not sponsor work authorization or visas for this role.