QC Lead Associate II (Microbiology)

Overview

The QC Microbiology Lead Associate II is a position that supports a broad range of microbiological disciplines and manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory. The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with little to no supervision.  They are expected to follow procedures and have mastery of a variety of microbiological methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks.

 

Microbiological disciplines common to the laboratory include but are not limited to aseptic technique, environmental and clean utility monitoring, bioburden and endotoxin determination, Gram staining, non-host (culture purity) testing, stock culture preparation and maintenance, cell culture maintenance, and associated viral titer assays.  The position primarily works independently taking direction from their manager or senior department staff, meanwhile providing direction to junior analysts and peers within the department.  Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts.   

 

Incumbents in this role will have primary assigned responsibility for Environmental Monitoring functions or Microbiology support, depending upon department needs and individual capacity. 

External US

**Shift: 2nd, 2:00 pm – 12:00 am, Wednesday- Saturday***

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Main areas of responsibility include, but are not limited to:

Laboratory sample analysis and data management

Maintain a safe working environment within QC through adherence to site EHS policies and procedures.

Actively engaged in the on-time delivery of routine operations and annual objectives.

Maintains the QC Laboratories in a state of audit readiness, presents on tours for client and regulatory inspections.

Performs appropriate training requirements and compliance to assigned curricula.

ORGANIZATIONAL STRUCTURE:

This is an individual contributor position reporting to the QC Microbiology Manager.

SCOPE MEASURES:

This is an individual contributor position reporting to the QC Microbiology Manager.  The role scope is predominantly aligned to sample analysis and data review.

 

BACKGROUND REQUIREMENTS:

Minimum Education Requirements

BSc, in Microbiology or related technical field

Desired Experience

6-8 years related experience (4 years required with relevant MS degree) in GMP laboratory environment

Knowledge and experience of GMP Bioburden, Endotoxin and EM testing.

Experienced in the training of individuals in Microbiological testing.

Experience working in a lean manufacturing or six sigma environments

Experience with LIMS and other data management systems

 

Specific Skills and Competencies

• Must be flexible and able to manage and prioritize multiple tasks and assignments.
• The individual must have excellent verbal and written communication skills and comfortably and clearly articulate issues with peers and colleagues at all levels in the organization.
• Demonstrated capability in a cross-functional team environment, working cooperatively with others in effective ways that attain goals
• Capable of high through-put and high quality, RFT work
• Proficient technical writing skills
• Capable of recognizing process gaps and implementing improvements

 

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

 

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual