Records Retention Associate
Charles River Laboratories International
Charleston, SC, US, 29407
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
The Microbial Solutions Team located in Charleston, SC is looking for a Records Retention Associate to support our Regulatory Compliance team.
Working Hours: Monday - Friday 8:30-5:00pm
Job Summary
Responsible for electronic record retention, organizing and maintaining paper records that are secured and controlled in the records retention area. Responsible for documenting and keeping track of records being checked in and out of the records retention area. Ensure the records are compliant with current Good Manufacturing Practice (cGMP) Regulations and Standard Operating Procedures (SOP) and policies.
Roles and Responsibilities
• Place and retrieve retained material in a secure and controlled access retain area.
• Scan paper records into electronic copies and/or review scans to ensure the electronic record is a true copy of the paper records.
• Ensure electronic records are easily identified and accessible to locate on secured network.
• Organize and file Quality Records.
• Check-in/check-out materials from retention area and monitor status of checked-out materials.
• Provide retention documents upon request for review and/or copying within the retention area.
• Maintain the master list of historical Quality Records.
• Prepare and coordinate with all departments the disposition of records on an annual basis including inventory of records to be disposed.
• Evaluate and procure supplies to support the retention area.
• Conform to Standard Operating Procedures (SOPs) and policies, current Good Manufacturing Practice (cGMP) Regulations, and Safety Procedures.
• Perform all other related duties as assigned.
Job Qualifications
Qualifications
• Education: High school diploma or General Education Degree (G.E.D.) and Associate’s degree (A.A./A.S.) or equivalent desired in business or administrative assistant discipline.
• Experience: At least 2 to 3 years of office experience or administrative/secretarial training required.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Licensure: None.
• Other: Basic computer skills with departmental databases word processing (Word), and spreadsheet programs (Excel). Must be organized, have attention to detail and possess good problem-solving skills. Knowledge of GMP regulations, especially in relation to records retention requirements. Effective verbal and written skills.
Compensation Data
The pay range for this position is $21.35 - 23.35 USD per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
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 20,000 employees within 110 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 - 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.
Nearest Major Market: Charleston South Carolina
Nearest Secondary Market: South Carolina
Job Segment: Pharmaceutical, Laboratory, Biology, Biotech, Science, Research