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QA Ops Specialist 2

Charles River Laboratories International Inc (CRL)

Memphis, TN, US, 38118

QA Ops Specialist 2 Req ID #:  167013 Location: 

Memphis, TN, US, 38118 Memphis, TN, US, 38118 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  

ESSENTIAL DUTIES AND RESPONSIBILITIES

 

•Review manufacturing Batch Production Records (BPRs) and associated supporting documentation including logbooks, Quality Control (QC) testing reports, environmental monitoring reports, etc.

•Perform line clearance and provide general manufacturing support

•Supports product shipment and receipt of returns

•Support raw material review and disposition

•Review Building Management Systems reports

•Participate in departmental and cross-functional continuous improvement efforts

•Consistently set a high standard for quality of work

•Promote a safety mindset through daily actions and communication with team members

•Issue BPR and labels to Manufacturing.

•Serve as owner of assigned non-conformances, CAPA, change controls, or other quality system documents and collaborate to drive completion

•Review and approve documents in Master Control

•Prepare lot packages for disposition decision by management

•Other duties as assigned Job Qualifications  

•Minimum of 3 year GMP related experience in biopharmaceutical/ pharmaceutical or related industry

•BS/BA Life Science or related field

•Experience with GMP regulatory requirements

•Ability to multi-task effectively

•Excellent written and verbal communication skills

•Ability to prioritize daily activities in order to meet client needs within established time lines in a fast-paced environment

•Proficient in computer system use, including but not limited to Microsoft Office(Word, Excel, Power Point)

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 Cognate BioServices

Cognate BioServices, Inc., a Charles River Company, is the premier commercial-ready CDMO for cell and gene therapy needs. We are a dynamic, results-driven organization focused on providing the broadest range of expertise across the various cell types and technologies used in the commercialization of cell & gene therapies for regenerative medicine, cellular immunotherapy, and advanced cell therapy companies, organizations, and institutions.

We offer a unique combination of standard and custom services to companies across all points of clinical and commercial development. Our development and manufacturing services are focused on clients seeking rapid development of products from clinical studies into commercial manufacturing, with a unique capacity to handle all aspects of scale-up and commercial readiness.

Cognate leverages the combined know-how and expertise of its business, scientific, and technical teams to successfully develop and manufacture autologous and allogenic products across multiple cell-based technology platforms from start to finish, for you and your patients.

For more information, visit www.cognatebioservices.com 

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: Memphis

Job Segment: CAPA, Telecom, Telecommunications, Pharmaceutical, Operations, Technology, Management, Science

Job posted: 2022-04-13

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