QC Specialist

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.

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