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

This position is responsible for the processing of human blood products by manual or automated cell isolation equipment, ensuring appropriate laboratory inventory, and batch record documentation execution and review. It also performs QC testing and creates a certificate of analysis (COA) for completed products.

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.

• Ability to read and accurately follow safety rules, operating and maintenance instructions, and procedures.
• Ability to shift gaze from viewing computer screen at a distance of several feet to forms that are close by to compare data.
• Ability to work flexible hours
• Ability to work in a dynamic environment
• Detailed oriented
• Discretion in handling confidential and sensitive matters
• Establishes and maintains strong interpersonal relationships
• Excellent decision making/problem-solving skills
• Excellent interpersonal skills
• Excellent oral & written communication skills
• Excellent relationship building skills, internal & external
• Excellent time management skills; ability to complete assignments within established timelines
• Has a strong work ethic and unwavering commitment to corporate guidelines and directives
• Is self-motivated and a self-starter
• Maintains a positive attitude
• Proficient use of Microsoft Office products including Word, Excel, Outlook, and PowerPoint
• Works collaboratively and builds consensus among diverse stakeholders

EDUCATION, EXPERIENCE, AND LICENSURE

• High School Diploma or GED; Associates Degree is preferred
• At least 1-year general lab experience, with Blood Donor Center experience preferred.

ESSENTIAL RESPONSIBILITIES

• Performs product quality control (QC) and certificate of analysis (COA) creation. Records, interprets, reviews and reports test results. Ability to recognize and investigate unacceptable test results.
• Performs processing of blood products into leukopaks using manual processes and automated equipment by following Standard Operating Procedures (SOPs), Good Manufacturing Practices (cGMP’s) and other regulatory agency procedures.
• Calibrates and runs flow cytometer and automated hemocytomer
• Can operate basic lab equipment (i.e., centrifuge, microscope, hemocytometer, incubator)
• Follows detailed protocols and instructions.
• Build production kits
• Reviews of production batch records for accuracy. Generates reports, stores completed work in designated locations and performs backup operations. Resolves discrepancies by using standard procedures or returning incomplete documents for resolution.
• Performs preventative maintenance procedures of laboratory equipment as assigned, maintaining records in compliance with manufacturing and regulatory guidelines.
• Exercises some independent judgment in resolving issues
• Confers with manager for resolution of problems
• Ability to identify and aid in the investigation of deviations.
• Contributes to error/accident reports, related root cause analysis, corrective actions, preventive actions, and follow-ups, as applicable.
• Orders lab supplies and ensures the lab is appropriately stocked for processing procedures
• Ensures the lab is appropriately stocked for processing procedures
• Responsible for inventory and ancillary supply restocking, expiration date checking, monitoring controlled environments, physical inventory, loading and unloading of various stock items.
• Knows and follows safety rules relative to area(s) or responsibility.
• Labels blood products, including assigning labels and recording information
• Ability to recognize and investigate unacceptable test results.
• Applies knowledge and skills to complete a wide range of tasks
• Is comfortable working with ambiguity in a dynamic and changing environment
• Accurately performs quarantine, destruction, and release of blood products. Labels blood products, including assigning labels and recording information.
• Identifies and troubleshoots problems encountered in assigned tasks and properly document corrective actions; notifies Management of non-compliance issues
• Is able to read, interpret, and understand the company and industry manuals and compliance standards and regulations.
• Presents a professional image to customers, internal and external.
• Performs tasks related to essential responsibilities within the scope of experience, abilities, and authority.
• Understands when to seek input and when to make independent judgments; prioritizes appropriately and makes productive use of time.
• Performs additional duties as assigned.

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.

• Ability to read and accurately follow safety rules, operating and maintenance instructions, and procedures.
• Ability to shift gaze from viewing computer screen at a distance of several feet to forms that are close by to compare data.
• Ability to work flexible hours
• Ability to work in a dynamic environment
• Detailed oriented
• Discretion in handling confidential and sensitive matters
• Establishes and maintains strong interpersonal relationships
• Excellent decision making/problem-solving skills
• Excellent interpersonal skills
• Excellent oral & written communication skills
• Excellent relationship building skills, internal & external
• Excellent time management skills; ability to complete assignments within established timelines
• Has a strong work ethic and unwavering commitment to corporate guidelines and directives
• Is self-motivated and a self-starter
• Maintains a positive attitude
• Proficient use of Microsoft Office products including Word, Excel, Outlook, and PowerPoint
• Works collaboratively and builds consensus among diverse stakeholder