We invite you to join our growing team!
Are you a QC LIMS Administrator looking for an exciting opportunity with an organization where you can have an impact on global health and wellness?
We are looking for an individual who will lead and oversee the selection, validation, and routine QC testing using a LIMS system at our FDA approved CDMO facility. Are you a person who thinks out of the box and who is looking for a new challenge? Do you naturally create new ways to deliver exceptional results? We want to meet you!
INCOG’s Why: Patient Impact
There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.
At INCOG, we are more than just a contract development and manufacturing organization. We are a company born out of a simple idea—that there has to be a better way. A better way to work with our customers. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are—a dedicated team that believes we can always be better.
Join us in building a world-class CDMO for parenteral injectable drugs and shaping a new future for patients for yourself, our clients, and patients.
Working at INCOG
We VALUE excellence, innovation, accountability, partnership, transparency, and results. We strive to be different putting our team at the forefront of everything we do and every decision we make. At INCOG, we are actively creating a culture where our team members are encouraged to be innovative, service-oriented, and collaborative problem solvers who are dedicated to meeting the challenges of working at a high-growth company. We are committed to empowering our employees to be their best and to making INCOG a rewarding and fun place to work.
We truly believe that every employee contributes to the success of the company, and you can be part of that team.
Our Values (ALP)
All IN
Patient Impact
Bring a positive attitude and best efforts, every day
Company commits to your growth and success, professional and personal
LEAN FORWARD
Have a bias for action
Be service-centric and solution-oriented
Welcome challenging projects and timelines
Work to be flexible with well designed systems and protocols
PULL FOR THE TEAM
Our customers’ success comes first
Treat others with respect; help rather than criticize
Celebrate the wins!
QC LIMS Administrator Summary
We are seeking a QC LIMS Administrator that has a passion for leading projects and processes, and is familiar with transformational, situational, and servant leadership concepts. The QC LIMS Administrator will work closely with the Director of Quality Control, QC Technical Services, and IT to help INCOG select and validate its LIMS software platform. Additionally, the LIMS Administrator will be responsible for creating and modifying master data associated with QC instrumentation and QC test methods as well as using LIMS to generate sample labels, perform sample tracking and reconciliation, and scheduling of QC personnel and equipment.
The QC LIMS Administrator will be influential in championing and developing our Quality Mindset through ingrained quality with skills including attention to detail, on time delivery, and efficiency into the Quality Control organization you will help build. Excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences is critical in this role. The QC LIMS Administrator will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, customers, suppliers, and partners. The QC LIMS Administrator will thrive in a team environment but can also work autonomously with strong self-management and organizational skills. Additionally, the QC LIMS Administrator will possess a demonstrated ability to influence positive outcomes without direct reporting authority.
Essential Job Functions:
Help select and validate the LIMS software platform used at INCOG.
Create INCOG process for generating and maintaining Master data for:
- Test methods
- Sample labels
- Stability protocols
- Environmental monitoring schedules
- Instruments
- Standards and Reagents
- Certificate of Analysis (COA) generation
- Custom LIMS reports
Serve as primary point of contact (POC) for other INCOG departments (Supply Chain, MSAT, Project Management, Validation, Quality Assurance) needing reporting or other data from LIMS.
Coordinate and design sampling plans and author and issue certificates of analysis templates.
Participate in material planning and Ready to Execute meetings to provide updates on material sampling and material release.
Partner with QC laboratory and IT leadership to ensure instrument connectivity to LIMS software both during initial procurement, as well as during changes or system upgrades.
Act as primary point of contact (POC) for technical or system-use needs with LIMS software vendor(s) in conjunction with INCOG IT. Will work with the IT LIMS Program Manager as a teamed approach to implement and manage the LIMS system and its key processes, inclusive of design decisions, instrument integration, and process controls.
Utilize various paper and automated systems (QMS, LIMS, etc.) to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.
Special Job Requirements:
- Bachelor’s degree in science or information technology.
- Minimum of 5 years of biopharma industry experience, of which at least 2 years have been in a role of hands-on experience with Quality Control in a regulated environment.
- Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control, in particular deployment of validated LIMS software platforms.
- First-hand experience participating in and/or hosting audits/inspections related to Quality Control.
- Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, PowerBI, JMP, Minitab, etc.).
Additional Preferences:
- Experience with QC instrumentation.
- Experience with SaaS IT systems.
- Experience with PowerBI.
INCOG’s Benefits:
- Paid time off, based on tenure
- 9 observed holidays + 2 floating holiday
- 401(k) plan with company match up to 3.5% of salary, vested immediately
- Choice of health & wellness plans
- FSA and HSA programs
- Dental & vision care
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
