The QC Lead Associate II is a senior analyst position and is responsible for both sample analysis as well as coordination of laboratory processes in the QC Microbiology laboratory.
The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of microbiological methods and supporting data management processes. Microbiological disciplines common to the laboratory include, but are not limited to: aseptic technique, bioburden testing, endotoxin determination (kinetic chromogenic, gel clot), environmental and clean utility monitoring, Gram staining, and culture purity testing. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matters experts. The ideal candidate also has experience with automated and/or rapid microbiological methods.
In addition to supporting sample testing, this position is also responsible for developing, maintaining and improving laboratory processes. This may include, but is not limited to, working with internal functions to ensure material and equipment readiness, interfacing with vendors, and implementing continuous improvement projects in the QC Microbiology laboratory.
The ideal candidate will supplement these roles with experience in one or more of the following topics, thereby expanding the subject matter expertise of the QC Department:
- Automated bioburden or endotoxin technology
- Microbial identification and assessment
- Trending of environmental monitoring data
This position will provide testing and coordination support in the microbiology laboratory. This is a 1st shift, Monday – Friday position.
Other duties and responsibilities include:
- Informs/consults with management regarding resource conflicts.
- Responsible for a broad range of laboratory support functions and procedures as assigned, demonstrating expertise in technical skills, disciplines, and procedures within assigned discipline area(s)
- Support all necessary laboratory and assay functions, including housekeeping, safety, logbook use and maintenance, equipment use and maintenance, method execution and data review.
- Embrace lean lab and six sigma principles and applies them to laboratory processes
- Reviews technical data and provides expert review and input to new methods and revisions.
- Notifies management and initiates events (such as deviations) in the quality systems
- Prioritizes and organizes work to deliver assignment according to established schedules and deadlines. May coordinate logistics associated with laboratory testing or supporting documentation with others in group
- May provide technical services (such as preparing reports and initiating deviations) from preexisting templates.
- Capable of meeting schedule RFT, high quality effort, taking initiative to communicate, coordinate, and adjust work efforts to achieve these objectives.
- Trainer within areas of proficiency
- Assists with deviations, lab investigations, procedure changes, method transfer planning
- May have some assigned project responsibilities, such as department representation, document development or review, troubleshooting, and protocol execution.
- Contributes to achievement of team goals and sense of teamwork within unit and across department
- Identifies and solves problems while informing and consulting with area management
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Lab Coordination activities- 45%
- Laboratory analysis- 45%
- Other activities- 10%
Minimum Education Requirements
- BS/BA in science, preferably in microbiology, biology, pharmaceutical sciences, or related technical field
- 6-8 years related laboratory experience (3 years required with relevant MS degree)
Specific Skills and Competencies
- Possesses an understanding and knowledge of procedures and practices in assigned area
- Has developed basic technique skills and is capable of working within established procedures
- Capable of working with a moderate degree of supervision and organizing own time
- Familiarity with basic statistical tools to analyze data in relation to trends results
- Familiarity with data management processes such as Trackwise or LIMS or capability to learn basic use and navigation within the systems.
- Capable of identifying and escalating problems to superiors
- Can manage one or more tasks in a manner that promotes effective schedule adherence.
- Ability to manage changing priorities in a productive and positive manner
- Can communicate effectively with colleagues in department, building trust and respect
- Ability to learn and incorporate lean lab and six sigma principles into daily work environment.
- Able to achieve Yellow Belt Certification within company six sigma program
- Technical writing skills (write basic protocols, prepare complex reports without a template)
- Problem solving and troubleshooting competencies
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 orientation, gender identify or any other protected class.
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 orientation, gender identify or any other protected class.