Documentation Data Reviewer II

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Short Description

HOURLY RATE : The pay for this position is $23.50/hr USD. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

SCHEDULE : Monday - Friday 8:00am - 4:30pm (must be onsite 5 days a week)

We are currently seeking a Documentation Data Reviewer II for our Quality Control team located at our Mattawan, MI site.

Quality Control supports the review and archival of analysis performed and provides administrative support to the Project Scientists in Laboratory Science disciplines that may include dose formulations, large and small molecule analysis, molecular and cell-based assays, Biomarker, and flow cytometry-based lab work. Staff participate in the review of methods; equipment records and the creation of report tables. Staff participate in the tracking and managing study related materials, providing requested data/information to the Project Scientist or Sponsor as required. Staff are knowledgeable in the application of GxP’s and applicable SOPs, protocols and ensuring adherence to regulatory documents.

Essential Duties And Responsibilities

• Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.).
• Demonstrate effective communication skills through informal discussions with peers, supervisor, and team.
• Accurately identify and effectively communicates any issues with data.
• Effectively support administrative tasks including but not limited to, filing, ordering, distribution of documents and study related materials as needed.
• Independently compile and archive data books and departmental records.
• Develop critical thinking, troubleshooting and time management skills aligned with needs of operational area.
• Review and issue data sets in adherence to established timelines.
• Accurately review departmental and study specific data to ensure adherence to SOPs, methods/protocols, industry standards, and regulatory requirements as applicable in timely manner.
• Oversee and maintain responsibility for one operational area with minimal oversight.
• Identify data discrepancies involving collection and analyses compared to study plan by working with appropriate personnel with oversight.
• Ensure sample analysis data collected is accurate against study plans, methods/type of analysis conducted and subjects' collection time points with oversight.
• Create and compile report tables with oversight.
• Review methods for accuracy, consistency and formatting with oversight.
• Review and monitor study schedules to ensure timelines are met with oversight.
• Ensure documents align with requirements indicated in Client Information Database (CID).
• Attend study and/or department related meetings to assure understanding of assigned projects.
• Attain CRL personnel and Sponsor signature/approval for study documents and distribute documents when necessary.
• Assist in preparation, review and/or processing of specialty data shared with Sponsors.
• Independently generate and maintain standard and complex draft study plans/protocols/amendments and reporting templates in accordance with CRL or Sponsor specific requirements within one operational area.
• Review laboratory study data to provide financial information for Unit Based Invoicing.
• Perform all other related duties as assigned.

Job Qualifications

• Bachelor’s degree (BA/BS) or equivalent in a relevant field with no previous work experience.
• Ability to communicate verbally and in writing at all levels inside and outside the organization.
• Basic familiarity with Microsoft Office Suite.
• Computer skills, commensurate with Essential Functions, including the ability to learn a validated system.
• Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice.
• Ability to work under specific time constraints.
• Must be authorized to work in the United States without a sponsor visa, now or in the future.

About Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

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