Data Analyst II, Quality Control

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.

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
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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.

• 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.

• 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…