For over 40 years, Charles River Cell Solutions has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies.
We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making Cell Solutions a rewarding and valuable place to work. We believe in making a difference, and at Cell Solutions, you will make a difference every day.
Job Summary
The Manufacturing Associate I will be responsible for assisting in the manufacturing of GMP products, Research Use Only products, and products for further manufacturing in controlled and un-controlled environments, utilizing guidance documents and batch records for process documentation. This individual shall assist in supporting core manufacturing requirements of the facility, including readying consumables, supporting and maintaining the in/outflow of critical manufacturing components, and contributing to document authorship.
Essential Responsibilities
Participate in aseptic production of human primary cells within the cleanroom suite using accompanying documentation according to GMP guidelines. Verifies entered data by reviewing and sending for correction/reentry of data. Assist with preparing products for dispensing into bags and unit dose packaging.
Performs tasks to prepare documentation for sampling site, incubator ID, batch number, and microbiological identification outside of clean room. Performs per-batch personnel monitoring on each sterile staff member. Performs weekly and per-batch environmental monitoring in sterile area(s). Reads and records the results.
Labels blood products, including assigning labels and recording information
Prepares equipment by performing sterile cleaning-in-place (CIP), servicing-in-place (SIP), and cleaning out-of-place (COP). Performs daily cleanings, monthly cleanings, and checks off on weekly cleanings, as well as ensuring removal of expired APIs.
Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks. Maintain proper control of operations by following SOP's, Manufacturing Procedures, GMP's, ISO requirements, OSHA guidelines, and other pertinent regulatory requirements.
Complies with all state and federal laws, rules, and regulations governing the practice of manufacturing and blood banking, including HIPAA. Stops at-risk behavior of others and self.
Demonstrates thorough knowledge of the job, completing all annual competencies and skill validations, all initial and on-going validations, and advanced media-fill verifications, and continuously attains new knowledge. Prepare, perform, and report proficiency testing. Maintain the ability to a pass cleanroom gowning qualification and work within manufacturing cleanrooms as necessary.
Use of the cell counter to generate QC data for in-process cleanroom operations. Record, interpret, review and report test results. Ability to use and analyze data from the flow cytometer for in-process cleanroom operations. Ability to recognize and investigate unacceptable test results.
Ability to identify and aid in the investigation of deviations.
Generate reports, store completed work in designated locations, and perform backup operations. Resolves discrepancies by using standard procedures or returning incomplete documents for resolution. Ability to review and complete all the documents/results needed for all the GMP product batch records.
Tracks and maintains raw materials, gowning supplies, and other inventory for the maintenance of the cleanroom and other supportive areas. Responsible for inventory and ancillary supply restocking, expiration date checking, monitoring controlled environments, physical inventory, loading and unloading of various stock items.
Performs maintenance and cleaning of cGMP/clean room areas. Assist all contractors to assure that work is done properly, and safety guidelines are observed. Supervise cleanroom maintenance work in or outside the cleanroom.
In addition to the aforementioned tasks, perform/execute other duties as assigned
Job Qualifications
To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Meets department quality standards.
Good time management skills: ability to complete assignments within established timelines.
Education, Experience, and Licensure
High school diploma or equivalent required. College credits or college degree preferred.
1+ years of experience of clinical and/or pharmaceutical lab experience.
Experience working within a GMP environment preferred.
Proficient use of Microsoft Office products including Word, Excel, Outlook, and PowerPoint.
Ability to quickly learn new software programs as needed.
Compensation Data
The pay rate for this role is $22.84 - $25.53 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 Charles River Cell Solutions
Charles River Cell Solutions is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development. Cell Solution's vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections.
In January 2020, HemaCare was acquired by Charles River Laboratories, an early-stage contract research organization (CRO). Combined with Charles River's integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs and enhances their productivity and effectiveness to increase speed to market. We work closely with our clients throughout the clinical process to maximize success and drive positive clinical outcomes.
Together, 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 and 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
At Cell Solutions, we are passionate about our role in improving the quality of people's lives. We have proudly supported the development of 100% of the current commercially available FDA-approved immunocellular therapies. Our mission is to provide a best-in-class portfolio of high quality, customizable human cellular material and services to support drug discovery, scientific research, and cell therapy. This resonates from our employees and impacts our customers because we know that every day is an opportunity to advance discoveries and make a difference in someone's life.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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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