Jobs
>
Durham

    Quality Assurance Floor Support Specialist - Durham, United States - Eli Lilly and Company

    Default job background
    Full time
    Description

    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.

    Lilly is a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to be part of the Lilly team working in a state-of-the-art parenteral facility using isolator technology and a fully automated visual inspection.

    The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to the QA Parenteral Associate Director. Responsibilities include performing AQL inspections, final classification of defects, sample management as well as providing QA oversight to GMP operations in the Parenteral visual inspection areas which includes automated visual inspection, semi- automated inspection, and manual inspection. QA Floor Support Specialist oversees visual inspection production functions to achieve patient safety and site goals through effective quality oversight.


    Responsibilities:

  • Ensures regular presence in assigned parenteral areas to perform AQL inspections, manage sample collection/deliver to laboratories.
  • Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.
  • Responsible for ensuring training is completed and remains in compliance.
  • Communicates with QA Representative and QA Parenteral Associate Director on quality and operational issues.
  • Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
  • Advise Operations and support personnel on quality matters, while driving the site Quality culture.
  • Reviews and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance.
  • Provide QA systems support to reconcile issues in systems; such as, inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise, PMX).
  • Participate in self-led inspections and provide support during internal / external regulatory inspections.
    Basic Requirements:
  • High School Diploma or equivalent
  • Demonstrated experience in GMP facility
  • 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., H-1B or TN status) for this employment position.
  • Must pass a vision exam and be free of color blindness
  • Must be equivalent to 20/20 correctable close vision acuityAdditional Skills/Preferences:
  • Parenteral Inspection experience (automated, semi-automated and manual).
  • Associate degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
  • Strong understanding of quality systems in the inspection environment.
  • Demonstrated strong oral and written communication and interpersonal skills to communicate to operators and management.
  • Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems.
  • Strong attention to detail and demonstrated organizational skills.
  • Basic computer skills including Microsoft Office products, (Excel, Word, PowerPoint, Outlook), inventory control (SAP), and electronic batch records (PMX)
  • Ability to work cross functionally and work collaboratively with all levels of the organization.
  • Proven ability to work independently or as part of a team to resolve issues.
    Additional Information:
  • Shift Monday - Thursday or Tuesday - Friday, 10 Hours (Day Shift)
  • Ability to work overtime, as requested.
  • Ability to wear safety equipment (safety glasses, safety shoes, protective gloves, etc.) and follow site gowning requirements.
  • Physical Demands: Light work that requires physical effort. Requires good communication skills, eye-hand coordination and manual skills. Occasionally requires force to raise, to load, and to push objects. Occasionally requires movements of the body like to incline, to climb, to kneel, to bend, to rise, and to walk down stairs.
  • Must pass an annual vision test and be free of color blindness.
  • Must be equivalent to 20/20 correctable close vision acuity Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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. #WeAreLilly


  • Vaco Durham, United States

    Unable to partner with 3rd party vendors (Corp-to-Corp/C2C) for this opportunity. · We are unable to sponsor at this time. · Relocation is not provided. · Job Summary: · Our biotech client is seeking a dedicated Onsite IT Support Specialist to join their growing organization. Thi ...


  • Optomi Durham, United States

    Tier II Support Specialist (On-site) · *This position will require an on-site presence in Durham, North Carolina* · Optomi, in partnership with one of our premier clients, is seeking a Tier II Support Specialist to join their team This candidate will be responsible for Tier I sof ...


  • North Carolina Central University Durham, United States

    Primary Purpose of Position · • Completes and processes applications: reviews application for completion and ensures all required documents are received; reviews application materials for conflicts; receives and matches addendum and character and fitness statements from applican ...


  • Lucid Services Group Durham, United States

    A leading North Carolina employer is in current need of a highly-motivated Technical Support Engineer to join their team to assist with some major initiatives and projects. This is an excellent opportunity for someone looking to expand upon their current technical support by work ...


  • BioCryst Pharmaceuticals Durham, United States

    ** Technical Support Specialist** · **Job Category****:** Information Technology **Requisition Number****:** TECHN001410 Showing 1 location **Job Details** · **Description** · **COMPANY:** · *At BioCryst, we are passionate about advancing novel therapeutics for patients with ...


  • RI International, Inc. Durham, United States Part time

    RI International is the leader in Peer-Powered Support to those in crisis for mental health and substance use. Our Mission is to empower people to recover, succeed in accomplishing their goals, find meaning and purpose in life, and reconnect with the Support Specialist, Support, ...


  • Accentuate Staffing San Francisco, United States Permanent

    Accentuate Staffing is seeking a Sales Support Specialist for a client in Durham, ; The Sales Support Representative will play a key component in the success of the Sales Department in building and maintaining a strong relationship with internal/ external stakeholders, clients, a ...


  • North Carolina Central University Durham, United States

    The person hired for this position will serve as a specialist in the School of Laws Academic Support Program. Required Knowledge, Skills, and Abilities - Excellent oral and written English communication skills. - Excellent organizational and time ma Support Specialist, Support, S ...


  • Durham County Durham, United States

    Durham County Government employs approximately 1,900 employees that work towards providing needed services throughout the community. With a wide array of services, Durham County Government is at the heart of a rapidly growing and diverse area offering residents, employees and vis ...


  • Church World Service Durham, United States Part time

    Overview · Robeson County Disaster Recovery Coalition, Inc. is committed to ensuring that individuals and families impacted by disaster fully recover. We understand that when disasters strike, they tear apart the fabric of community. All too often those living in underserved com ...


  • Durham County Durham, United States

    Durham County Government employs approximately 1,900 employees that work towards providing needed services throughout the community. With a wide array of services, Durham County Government is at the heart of a rapidly growing and diverse area offering residents, employees and vis ...


  • North Carolina Central University Durham, United States

    The Office of Academic Success provides a variety of resources to ensure that all students develop the skills needed to succeed academically at the School of Law. Through Academic Success and Bar Preparation courses, the tutorial program, workshops, individualized academic counse ...

  • Avalara

    HR Support Specialist

    2 weeks ago


    Avalara Durham, United States

    Overview: · As our HR Support Specialist to join our growing Global People Operations team. This is a perfect position for someone who already has entry level Human Resources and Workday experience and is ready to take the next step in growing their career. You will use your HR ...


  • North Carolina Central University Durham, United States

    Posting Details · Position Information · Working Title · Academic Support Specialist · Position Number · 617459 · Appointment Type · Permanent - Full Time · Tenure Track · No · FTE · 1 = 40 hours/week, 12 months · If time limited, duration date · Position Overview · Primary F ...


  • Cynet Systems Durham, United States

    Job Description: · Responsibilities: Receive and process enrollment requests into the CRM system, following up to obtain any missing information. · Provide customer phone support for enrollment questions and issues. · Support investigation and resolution of duplicate records. ...


  • Recovery Innovations Durham, United States

    RI International is the leader in Peer-Powered Support to those in crisis for mental health and substance use. · Our Mission is to empower people to recover, succeed in accomplishing their goals, find meaning and purpose in life, and reconnect with themselves and others. · Our Vi ...


  • SouthLight Durham, United States

    Certified Peer Support Specialist - Durham County · Join a supportive team who values Compassion, Excellence, Collaboration, Inclusion, Hope, & Authenticity · As a Certified Peer Support Specialist on our Durham County team, you will provide your assigned caseload individualized, ...


  • RI International Durham, United States

    Job Description · RI International is the leader in Peer-Powered Support to those in crisis for mental health and substance use. · OurMissionisto empowerpeople to recover, succeed in accomplishing their goals, find meaning and purpose in life, and reconnect with themselves and o ...


  • Novartis AG Durham, United States

    Summary · Location: Durham, NC #onsite Relo statement: Novartis is unable to offer relocation support for this role. The Specialist, Manufacturing Technical Support, provides front line authority support for all process-specific issues to manufacturing, to ensure execution of pro ...


  • Department of Veterans Affairs Durham, United States

    Summary · This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific individual eligibility requirements in accordance with VHA policy and submit your EDRP application within four months of appoi ...