What are the responsibilities and job description for the QC Specialist - LIMS position at Eurofins?
Company Description
The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
If you’re looking for a rewarding career, a place to call home, apply with us today!
Job Description
This position will be part of the Technical Services team building the BAU model to support Quality and Manufacturing in an efficient and agile manner. The Role is primarily responsible for the day-to-day support of the site LIMS System and GMP Process associated with the generation and maintenance of GMP Master data, as well as support the site end-user operational needs as required. Responsibility for the day-to-day maintenance of gLIMS, including but not limited to:
Data to Day operational Master data activity
- Receiving, tracking and completing all gLIMS actions on QTS in a timely manner.
- Building all Masterdata in accordance to gLIMS Master Data Configuration Standards (CD-026972) & gLIMS Master Data SOP-00671.
- Completing all gLIMS verification testing using ALM in accordance to the global SOPs.
- Complete all defect management in ALM for all Master Data Objects.
- Site POC for all gLIMS queries and troubleshooting, resolving where possible or escalating to the appropriate external team when necessary.
- Support the Environmental module and associated periodic trend reports
gLIMS Application Releases
- Assess all releases (major & minor) using the release notes issued and attend any release note meetings.
- Represent the site on release note meetings, User council meetings etc.
- Participate in all meetings to ensure sites needs are raised in the correct forum
- Perform Periodic Review and UAR for gLIMS as required
- Support data integrity audits and other Regulatory audits as required
- Raise enhancements to the gLIMS as needed by site.
- Support Core testing and design of future enhancements.
SOPs & Training
- Maintain gLIMS SOP’s in an effective state
- Deliver site training on all gLIMS modules to end users withing scope of you Job role.
- Work with BTAMS for account creation, modification and revoking.
Additional Responsibilities
- Empower Master Data creation
- Help with computer software management in the QC Lab
Qualifications
BASIC MINIMUM QUALIFICATIONS:
- 2 years of experience in the Master data process associated with the site LIMS systems is required
- The ideal candidates for this role must have strong teamwork and communication skills.
- Must demonstrate a pro-active approach to all problem solving and trouble shooting.
- Have an understanding of how the site operates in order to build suitable gLIMS Masterdata
- Be comfortable in cross functional teams where gLIMS input are needed.
- Be Customer & Quality focused.
- A Working Knowledge of SAP, QTS, PDOCS, ALM, and BI Data warehouse is desirable.
- Be a self-starter with the ability to work on their own initiative and within teams.
- Have creativity to identify improvement opportunities and the initiative to see them implemented.
- You should be able to demonstrate a proven track record in delivering the sites fundamentals of safety, quality, supply and cost in line with the 11 Safety & Quality Excellence (SQE) principles.
- Strive for continuous improvement within the Quality Systems Group.
Additional Information
Position is Full Time, Monday-Friday, 8:00am-5:00pm. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.
- Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Eligibility for potential yearly Bonus & Merit-Based Pay Increases
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
