Lead QC Associate II- Microbiology Data Reviewer

Overview:

The QC Lead Associate II - Data Reviewer is a senior analyst position able to perform independently in a high throughput, right-first-time, GMP laboratory environment, while meeting production schedules and project milestones.

The primary responsibilities for this role are to ensure that all data generated in the QC Microbiology laboratory is technically sound, meets ALCOA+ requirements, and is available to support business and project timelines. The reviewer will be responsible for identifying errors, ensuring GMP compliant corrections when possible, and escalating to management when appropriate. The reviewer will not be responsible for scheduling or overseeing testing, but may be consulted for project planning or investigation support. The reviewer may be responsible for creating reports and/or CoA's based on the data generated.

External US:

The QC Lead Associate II - Data Reviewer is a senior analyst position able to perform independently in a high throughput, right-first-time, GMP laboratory environment, while meeting production schedules and project milestones.

The primary responsibilities for this role are to ensure that all data generated in the QC Microbiology laboratory is technically sound, meets ALCOA+ requirements, and is available to support business and project timelines. The reviewer will be responsible for identifying errors, ensuring GMP compliant corrections when possible, and escalating to management when appropriate. The reviewer will not be responsible for scheduling or overseeing testing, but may be consulted for project planning or investigation support. The reviewer may be responsible for creating reports and/or CoA's based on the data generated.

The assays for which this role will perform data review include but are not limited to: bioburden analysis (membrane filtration), endotoxin analysis (KTA, gel clot), culture purity testing, environmental and utility monitoring, and organism identification. The successful candidate will have previous experience with most or all of these assays, as well as general operations in a GMP microbiology laboratory. Data is recorded and stored in a variety of systems, both paper-based and computerized (Labware LIMS, SoftMaxPro). The reviewer must achieve proficiency with all applicable systems.

The reviewer must be knowledgeable about all applicable procedures and requirements, and is expected to act as a Subject Matter Expert resource for junior analysts.

This is a 1st shift, Monday - Friday, site-based position.

Other duties and responsibilities include:

Informs/consults with management regarding GMP data

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 as able

May have some assigned project responsibilities, such as department representation, document development or review, and troubleshooting

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:

Data review - 80%

Other activities- 20%

BACKGROUND REQUIREMENTS:

Minimum Education Requirements

BS/BA in science, preferably in microbiology, biology, pharmaceutical sciences, or related technical field

Desired Experience

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 minimal 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 and 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.

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.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.