Lilly
Sr. Manager - QC Device and Incoming
Lilly, Concord, North Carolina, United States, 28027
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 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.
Position Brand Description:
The Device and Incoming QC Testing Team Leader provides direction and conducts daily workload planning, compliance, and overall customer service. The Team Leader must be approachable and will spend considerable time mentoring reporting staff. This role will be integral in designing and installing procedures and systems for the startup of the QC lab at the site.
Key Objectives/Deliverables:
Proactively manage day-to-day business, including interactions with project leaders and management to coordinate activities to set up the QC lab.
Once the lab is functional, manage day-to-day business by interacting with production planners and sample submitters to manage laboratory workload and throughput.
Maintain a high-level understanding of laboratory processes and be responsible for analyst and technician training on methods and proper sample handling.
Develop career plans for laboratory analysts and technicians.
Enforce compliance with all procedures, methods, and regulatory commitments.
Provide technical understanding of regulations applicable to laboratory testing for cGMP purposes.
Serve as a team change agent and safety agent.
Participate as primary laboratory subject matter expert for internal and external audits.
Responsible for maintaining a safe work environment and supporting all HSE Corporate and Site Goals.
Basic Experience Requirements:
Teamwork and interpersonal skills
Strong verbal and written communication skills
Deep understanding of compliance requirements and regulatory expectations
Familiarity with device and incoming testing
Ability to focus on continuous improvement
Minimum 7+ years of related experience in a regulated environment
Education Requirements:
Bachelor or Masters in a science or engineering discipline (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc.)
Additional Skills/Preferences:
Effective time management
Effective problem-solving skills
Experience with LabVantage LIMS
Demonstrated written and oral communication skills and ability to collaborate with management, scientists, engineering, and IT personnel
Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities
Other Information:
8 hour days – Monday through Friday
Required to carry a mobile phone off shift and respond to operational issues
Travel may be required during the project phase
Ability to work in various areas within the site; some allergens are present in the parenteral plant
Tasks may require repetitive motion (e.g., keyboarding)
Lilly is dedicated to helping individuals with disabilities engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. 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.
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Position Brand Description:
The Device and Incoming QC Testing Team Leader provides direction and conducts daily workload planning, compliance, and overall customer service. The Team Leader must be approachable and will spend considerable time mentoring reporting staff. This role will be integral in designing and installing procedures and systems for the startup of the QC lab at the site.
Key Objectives/Deliverables:
Proactively manage day-to-day business, including interactions with project leaders and management to coordinate activities to set up the QC lab.
Once the lab is functional, manage day-to-day business by interacting with production planners and sample submitters to manage laboratory workload and throughput.
Maintain a high-level understanding of laboratory processes and be responsible for analyst and technician training on methods and proper sample handling.
Develop career plans for laboratory analysts and technicians.
Enforce compliance with all procedures, methods, and regulatory commitments.
Provide technical understanding of regulations applicable to laboratory testing for cGMP purposes.
Serve as a team change agent and safety agent.
Participate as primary laboratory subject matter expert for internal and external audits.
Responsible for maintaining a safe work environment and supporting all HSE Corporate and Site Goals.
Basic Experience Requirements:
Teamwork and interpersonal skills
Strong verbal and written communication skills
Deep understanding of compliance requirements and regulatory expectations
Familiarity with device and incoming testing
Ability to focus on continuous improvement
Minimum 7+ years of related experience in a regulated environment
Education Requirements:
Bachelor or Masters in a science or engineering discipline (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc.)
Additional Skills/Preferences:
Effective time management
Effective problem-solving skills
Experience with LabVantage LIMS
Demonstrated written and oral communication skills and ability to collaborate with management, scientists, engineering, and IT personnel
Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities
Other Information:
8 hour days – Monday through Friday
Required to carry a mobile phone off shift and respond to operational issues
Travel may be required during the project phase
Ability to work in various areas within the site; some allergens are present in the parenteral plant
Tasks may require repetitive motion (e.g., keyboarding)
Lilly is dedicated to helping individuals with disabilities engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. 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.
#J-18808-Ljbffr