QA Specialist I
Rockville, MD, US, 20850
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 QA Specialist I is responsible to ensure that production process is client focused, results oriented, performance driven, and in compliance with all applicable internal and external requirements. The Quality Specialist I will release critical materials required for GMP operation on timely basis.
Key Responsibilities and Duties:
• Provide QA oversight and support to client projects while working closely with QA Management to ensure QA support for GMP operations for the manufacture of master/working cell banks, bulk drug substance, plasmid products and/or final drug product used for human consumption
• Perform audits and/ or walkthrough of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices
• Review executed batch production records and associated supporting documentation including logbooks, QC test reports, Environmental monitoring reports, cleaning records, etc.
• Perform QA on the floor activities supporting client projects, including line clearance and room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing
• Support in-process and raw materials review and disposition following approved internal procedure
• Ensure SOPs are current and effective, and staff performs routine tasks according to SOP through direct observation
• Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
• Actively participate in all recruiting efforts to secure, onboard, and develop new staff members
• Additional duties as assigned
Job Qualifications
• BS/ BA in life sciences or related fields
• Minimum 3 years of experience in GMP related experience in biopharmaceutical/ pharmaceutical or related industry, preferably 2 years of experience in batch record review process
• Previous knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines
• Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
• Strong verbal and written communication skills
• Strong organizational skills; able to prioritize and manage through complex processes/projects
• Ability to define problems, collect data, and draw valid conclusions
• Ability to organize and disseminate information efficiently and multi-task in a fast-paced environment
• Organized, responsible, creative, pays attention to detail
• Knowledge of Microsoft suite (Word, Excel, Access, Vizio and PowerPoint).
• The ability to follow instructions and Standard Operating procedures
• Ability to always maintain a professional and pleasant demeanor
Compensation Data
Pay rate for this role is $65,387 - $80,183 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
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 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 companies, 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.
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.
Nearest Major Market: Washington DC
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