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Scientific Data Analyst II - Quality Control

Charles River Laboratories International Inc (CRL)

Mattawan, MI, US, 49071

Scientific Data Analyst II - Quality Control Req ID #:  175915 Location: 

Mattawan, MI, US, 49071 For 70 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.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly. Job Summary  

Quality Control supports the review and archival of analysis performed by Laboratory Science disciplines that may include dose formulations, large and small molecule analysis, molecular and cell-based assays and Biomarker based lab work.   Staff participate in the review of methods; equipment records and the creation of report tables.  Staff are knowledgeable in the application of GxP's and applicable SOPs, protocols and ensuring adherence to regulatory documents.

Essential Functions (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed: 

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

Perform all other related duties as assigned Job Qualifications Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:

Bachelor’s degree (BA/BS) or equivalent in a relevant field with no previous work experience

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above

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

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19.  Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

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 120 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 18,000 employees within 100 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 supported the development of >80% of the drugs approved by the FDA for the past 3 years.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

 

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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

 

For more information, please visit www.criver.com.

Nearest Major Market: Kalamazoo

Job Segment: Pharmaceutical, Recruiting, Laboratory, Data Analyst, Scientific, Science, Human Resources, Data, Engineering

Job posted: 2022-05-25

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