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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.

Job Summary

NOTE: The shift schedule is 3-2-2-2-3 rotating schedule.

The Quality Operations Specialist II is responsible for reviewing manufacturing Batch Production Records and associated documentation, supporting product shipment and returns, and providing general manufacturing assistance, including line clearing. Additionally, they actively participate in continuous improvement efforts, ensure proper documentation approval, and play a role in preparing lot packages for management's disposition decision. Upholding a safety mindset and maintaining high standards for work quality are integral to this position.

• Provide 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 for equipment data

• Issue Batch Production Records and labels to Biomanufacturing

• Serve as owner of assigned nonconformances, Corrective and Preventive Action (CAPA) change controls, or other quality system documents and collaborate to drive completion

• Review and approve documents in Document Management Systems

• Prepare lot packages for disposition decision by management

• Observe live processing, review BPRs and other documents in real time within Cell Processing Facility (CPF) and corridor

• Practice and adhere to aseptic behaviors while observing in CPFs and corridors

• Escalate concerns to quality operations leadership through proper communication channels in a timely manner

• Demonstrate the ability to wear the required Personal Protective Equipment (PPE) while performing QOTF Duties

• Complete and submit QOTF daily reports

• Perform all other related duties as assigned.

Job Qualifications

• Bachelors degree in a Life Science and/or related field preferred High school diploma or equivalent required

• Minimum of 2 years GMP related experience in biopharmaceutical/ pharmaceutical and/or related industry

• Experience with GMP regulatory requirements

• Ability to multi-task effectively

• Excellent written and verbal communication skills

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

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

• Ability to problem solve and troubleshoot as necessary

• Consistently set a high standard for quality of workPromote teamwork and cooperation for departmental and cross departmental task and functions

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

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 supported the development of 86% of the drugs approved by the FDA in 2021.

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, or 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.

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