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Charles River Laboratories PTS Quality Operations Supervisor (1st Shift) in Charleston, South Carolina

PTS Quality Operations Supervisor (1st Shift)

Req ID #: 134951

Location:

Charleston, SC, US, 29407

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

We are seeking aPTS Quality Operations Supervisor (1st Shift)for ourMicrobial Solutionsbusiness located inCharleston, SC.

Responsible for assisting in the development and implementation of training and departmental testing procedures. Responsible for all PTS in-process testing, lot specific potency determinations and investigations associated with PTS cartridge in-process testing. Product performance responsibilities include gathering and analyzing production and testing related data to address management questions about trends. Operation responsibilities involve the tracking of departmental efficiency, and formulating and implementing recommendations for team training, development, and staffing.

The following are theduties & responsibilitiesrelated to thePTS Quality Operations Supervisor (1st Shift):

• Coordinate testing schedules with area managers.

• Assist in preparation of product testing reports and preparing for regulatory driven and/or customer audits.

• Develop testing strategies and design experiments that are necessary to identify, resolve, and close complex deviations.

• Manage all lot specific data. Ensure accuracy and conduct documented investigations when required.

• Ensure the timely review and accuracy for all batch specific records.

• Responsible for SOPs and training modules associated with operation of testing instruments and testing procedures.

• Identify, develop, and track critical product performance indicators for core LAL and PTS products; trend the indicators and interpret and react to those trends.

• Coordinate meetings to ascertain information and share status reports on on-going investigations and projects.

• Interview and select qualified non-exempt personnel. Recom¬mend personnel actions, including hiring, promotions and raises. Partner with Human Resources and depart¬mental management to assist in the handling of disciplinary issues. Draft appropriate personnel action paperwork.

• Oversee training and development of staff to ensure compliance with the testing requirements, CRL procedures, and Regulatory compliance.

• Monitor performance of direct reports. Provide regular coaching and counseling. Assist in preparation and delivery of salary and performance reviews of direct reports.

• Ensure optimum performance of group function. Recommend and implement techniques to improve productivity and increase efficiencies.

• Assist in the development, maintenance and communication of departmental systems and SOPs. Assist in the development and communication of job descriptions for subordinate positions.

• Ensure that departmental equipment is maintained in good working condition and that departmental area(s) are maintained in a clean and orderly condition.

• Perform all other related duties as assigned.

Job Qualifications

The following are theminimum qualificationsrelated to thePTS Quality Operations Supervisor (1st Shift):

• Education: B.S. in physical or biological sciences required

• Experience: 3-5 years related experience, preferably in cGMP or other regulated field.

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

• Certification/Licensure:None.

• Other: Proficiency with MS Office applications. Good working knowledge of cGMP procedures preferred.

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.

About Microbial Solutions

Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

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 17,000 employees within 90 facilities in 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. And in 2019, revenue increased to $2.62 billion.

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 85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

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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