Lead Technician- QA – PAR (Night Shift) Position Available In Merrimack, New Hampshire

Lead Technician QA PAR (Night Shift) locations
US, Concord NC
time type
Full time
posted on
Posted 21 Days Ago
job requisition id
R80735
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 lifechanging 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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Quality Assurance Floor Support Specialist is responsible for providing QA oversight to GMP operations. The role will provide QA support of the startup and qualification of the Concord site. The QA Floor Support Specialist will demonstrate teamwork by collaborating cross functionally with various levels of the organization. As the project progresses, this role will transition to supporting and escalating issues from manufacturing to the sitebased process team for one of the following manufacturing areas:

• Formulation and Equipment Preparation Processes
• Parenteral Filling (PreFilled Syringes)
• Automated and Semiautomated Visual Inspection

Responsibilities:

• Support onthefloor manufacturing activities with routine presence in the assigned manufacturing area.
• Follow good documentation practices and compliance with site procedures.
• Review and approve GMP documentation such as electronic batch records, logbooks, etc.
• Support creation of Standard Operating Procedures and associated Forms, Tools and Training.
• Troubleshoot and provide support to resolve equipment alarms and other issues in quality systems such as Trackwise and MES.
• Maintain open communications between cross functional teams and area leadership.
• Support the execution of inspection readiness activities including support of site selfinspections.
• Support project initiatives needed for the project and Quality function.
• Communicate any compliance issues associated with the project or site to Quality Management.
• Evaluate potential product quality impact for any GMPrelated incident and support the investigation and assist with safety investigations.

Basic Requirements:

High School diploma or equivalent
Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
Demonstrated ability to communicate with crossfunctional teams including good oral and written communication skills
Strong attention to detail
Ability to work independently with minimal supervision
Proficiency with computer systems including Trackwise, MES, Microsoft Programs
Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H1B or TN status) for employment positions on the B paths or at R1 Level.

Additional Skills/Preferences:

Associates or Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study, preferred
Previous experience with GMP manufacturing equipment prep, formulation, filling, and visual inspection
Previous experience with Manufacturing Execution Systems (MES) or electronic batch records
Previous technical writing experience
Technical aptitude and ability to train and mentor other team members

Additional Information:

Ability to work 12 hour shifts onsite on a rotating 223 schedule (not eligible for remote work)
Overtime and offshift support may be required
May be required to respond to operational issues outside of core business hours and days
May be subject to postoffer physical and vision exam
Job is exposed to repetitive movements such as: Walking, Sitting, Bending, Twisting
Must have ability to lift 30lbs
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 (careers.lilly/us/en/workplaceaccommodation) 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees.

Our current groups include:

Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$28.12 $51.68
Fulltime 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 companysponsored 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 wellbeing 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.
#WeAreLilly
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About Us
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
#WeAreLilly