Easter Seals Jobs

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$28.12 - $46.88

Organization Overview:

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Concord, North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

Position Description:   

The QA – Stat Sort Lead will have oversight of the daily operations of the Stat Sort group, daily batch scheduling, and will provide assistance in deviation investigations, change control proposals, procedures, training, and will be an inspection SME resource. Additionally, the role will provide QA support of the start-up, commissioning, and qualification of the Concord site.

The Sr. Specialist will also obtain all training and qualifications necessary to perform a statistical sort inspection and sampling on every batch of Lilly Parenteral Product within the Parenteral site.

Responsibilities:

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.

• Responsible for Syringe Defect Kit Management, including Automated Inspection Challenge kits, and Inspection Qualification kits.

• Capable of functioning in Leader capacity in absence of Leader.

• Assist Leader in development of QA Stat Sort Specialists.

• Participate in planning / scheduling of QA Stat Sort operations and be a technical leader / resource for QA Stat Sort Specialists.

• Review GMP documents (example: Non-conformances, procedures, protocols, and change controls).

• Evaluate potential Product Quality impact for any GMP-related incident and support the investigations and assist with Safety investigations.

• Ensure Good Documentation practices and compliance with operational procedures and work instructions with Operations and support personnel.

• Perform inspection of Syringes.

• Participates in Six Sigma Projects and Process Improvement Initiatives to improve productivity within the Quality organization and the process team.

• Provide oversight and assist with training of new Parenteral site visual inspectors.

Minimum Requirements:  

• Demonstrate strong leadership skills.

• Demonstrated relevant experience in a GMP facility.

• Demonstrated strong interpersonal skills and the ability to work as a team.

• Demonstrated organizational skills (planning, scheduling, and ownership).

• Demonstrated ability to learn quickly and utilize new skills.

• Autonomous efficient worker.

• Positive attitude and flexible.

• Computer skills in Microsoft Office Products including Outlook.

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

• Required to pass eye exam. (20/20 correctible vision acuity and free of color blindness)

Education Requirements:  

• High School diploma or equivalent 

• Demonstrated relevant experience in a GMP facility

Additional Preferences:  

• Associate's degree in a science, engineering, computer, or pharmaceutical related field of study, preferred. 

• Parenteral visual inspection experience

• Previous experience with deviation and change control process

• Experience in Production, QC, QA, Technical Services, or Regulatory

• Knowledge of cGMPpractices including good documentation practices, data integrity and regulatory compliance

• Experience as mentor or trainer

• Strong technical writing and oral/written communication skills

Other Information:

• Overtime and off-shift support may be required.

• May be required to respond to operational issues outside of core business hours and days.

• May be subject to Post-Offer Exam.

• Job is exposed to repetitive movements such as: Walking, Sitting, Bending, Twisting, etc.

• Ability to lift 30 lbs.

• Position is day shift (1st shift), minimal travel required.Role not eligible for remote work.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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.

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