Records Retention Associate

Company: myGwork
Location: Charleston
Posted on: March 16, 2023

Job Description:

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 We are seeking a - Records Retention Associate , for our - Microbial Solutions site -located in - Charleston, SC. This position is responsible for organizing and maintaining regulated records that are secured and controlled in the records retention area. Ensure the records are compliant with current Good Manufacturing Practice Regulations (GMP) and Standard Operating Procedures (SOP) and policies. Responsible for assisting QA Auditors in performing reviews of incoming materials, with the authority for subsequent approval or rejection of these items against material specifications as well as performing QA sample checks for final product as requested. ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Place and retrieve regulated records from secure and controlled access into record retention area.
• Organize, file and retrieve batch records, protocols, and other controlled records.
• Check-in/check-out materials from retention for regulatory and customer audits. Provide retention documents upon request for review and/or copying within the retention area.
• Maintain inventory of content within each file cabinet/box.
• Prepare and coordinate with all groups the disposition of documents on an annual basis including inventory of items to be disposed.
• Evaluate and procure supplies for the Records Retention Area.
• Scan retained documents as requested by Sr. Management. Assist QA Auditors in performing sample checks of completed batches of final product as requested.
• Assist QA Auditors in performing reviews of incoming raw materials for compliance with requirements detailed in material specifications as requested.
• Assure compliance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practice Regulations (GMP) for records retention area.
• Perform all other related duties as assigned. Job Qualifications
  • Education : High school diploma or General Education Degree (G.E.D.). Associate's degree (A.A./A.S.) or equivalent desired in business or administrative assistant discipline.
  • Experience : 1-2 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 (Access, Approach), word processing (Word), and spreadsheet programs (Excel). Must be organized, have attention to detail and possess good problem-solving skills. 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 This employer is a corporate member of
    myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals,
    students, inclusive employers & anyone who believes in workplace equality.
    

Keywords: myGwork, Charleston , Records Retention Associate, Other , Charleston, South Carolina