QC Lead Sample Receipt Analyst

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FDB call Genki. 

 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

 

Summary:  The Sample Management Analyst Lead will be responsible for mentoring the team on technical aspects of performing routine and non-routine support of samples submitted to the Quality Control (QC) Laboratory for evaluation. This position is a pivotal role to either a technical career path as a QC Sample Management Lead or a managerial career path as a lead for the team, and a successful individual in this role will lead the team regardless of the career path they decide to pursue.  

 

External US

Primary Responsibilities: 

• Follow Standard Operating Procedures (SOPs) and other related Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP) 

• Manage test samples, critical reagents and reference materials. 

• Perform shipments to external testing facilities and clients. 

• Help to maintain safety and orderliness of the lab: apply knowledge of cGMPs and GLPs on daily basis.  Ensure labs are maintained (Organized, clean, properly supplied). 

• Maintaining inventory 

• Fulfill QC Analyst sample requests. 

• Lead technical training for less experienced members of the team. 

• Technical Writing to include: 

• Writes and revises Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP) documentation as appropriate. 

• Lead the initiation and closure of deviations, CAPAs and Change Controls. 

• Ensure samples are put into SmartQC for testing. 

• Manage the tasks and delegate to Analysts under general direction. 

• Host daily shift meetings. 

• Identify deviations and report possible preventative and corrective actions using Trackwise. 

• Discuss inventory requests with Project Managers 

• Excellent written and oral communication skills. 

• Ability to work independently, along with ability to work well within a team. 

• Perform as a SME on sample management processes. 

• Previous pipetting experience. 

• Excellent attention to detail and ability to utilize problem solving/trouble shooting skills. 

• Computer proficiently. 

• Role model for company core values of trust, delighting our customers, Gemba and Genki. 

• Demonstrated leadership skills. 

• Able to multitask in a fast-paced environment. 

• Perform other duties as assigned. 

 

 Qualifications for External Candidates: 

• High School Diploma or GED, AND at least seven (7) years of relevant GMP Experience OR;   

• Associate’s degree preferably in Biochemistry, Chemistry, Biology or related field AND at least six (6) years of relevant GMP Experience OR;  

•  Bachelor’s degree preferably in Biochemistry, Chemistry, Biology or related field AND at least three (3) years of relevant GMP Experience OR; 

• Master’s degree preferably in Biochemistry, Chemistry, Biology or related field AND at least two (2) years of relevant GMP Experience 

  

Physical Requirements: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to: 

 

• Experience prolonged standing, some bending, stooping, and