|: Rockville, MD, USA|
|: Not Specified|
|: 2 months ago|
LOOKING FOR SOMEONE TO START ASAP
The QC Raw Material Specialist (I/II) is an integral part to the organization with direct impact on *** Rockville’s vision to make a difference in the lives of people globally. The QCRM Specialist is committed to supporting *** global biologics analytical network with reliability, integrity, active engagement, and cross functional collaboration. Under the direction of the QC Supervisor/Manager, the QCRM Specialist is responsible for performing data review, disposition of controlled materials (consumables or raw materials) for in raw materials under cGMP conditions. The role will support the manufacturing campaigns by ensuring raw materials disposition within established timelines. The individual must demonstrate the ability to handle multiple priorities and interface with individuals from various departments. Must demonstrate strong interpersonal skills, ability to interpret complex data and draw conclusions, ability to attention to detail, and to perform with minimal supervision.
KEY RESPONSIBILITIES: (10 bullet points maximum)
• Reviews the approved analytical test results and documents generated within QC Raw Material laboratory for technical and compliance content.
• Performs disposition (acceptance or rejection) of the controlled raw materials, accurately and in a timely fashion, within SAP system.
• Reviews and approves deviation investigations, out-of-trend results, and test failures associated with product manufacture, release testing and stability testing. Identify root causes of manufacturing issues and implement corrective action to minimize downtime with a focus on Safety, Quality, Delivery and Cost, in that order.
• Manages controlled material document records (CMDR) and maintains Raw Material Qualification program.
• Helps maintain compliant cGMP systems within the Raw Materials Laboratory. Writes/revises Standard Operating Procedures (SOPs) and Controlled Material Specifications.
• Supports authoring of technical documents (ex. analytical protocols, reports etc) within QC Raw Materials.
• Evaluates the compendia assessment provided by corporate; identifies the relevant changes which will apply to the site; ensures the corrective actions are in place if required.
• Author Periodic Product Review (PPR) Reports
• Works with supervisor/manager to conduct laboratory investigations related to raw material testing.
• Performs self-inspection and participates in internal and regulatory audits.
• Works through obstacles, performs, and completes routine assignments according to the written procedures in compliance with cGMP and minimal supervision. Able to seek additional tasks or non-routine functions and accomplish them.
• Striving for establishing a Right First-Time culture by reducing waste and constantly driving continuous
This role requires office work, laboratory walkthroughs, reviewing of chemical reagents that may be hazardous (corrosive, toxic, flammable etc.), computer work, group meetings, and thus involves sitting, standing, walking, repetitive motion.
This role requires occasional working outside of 0800-1700 hours for on call activities such as chamber management, performing ADHOC controlled material disposition or other activities that the QC Raw Material laboratory is responsible for.
B.S/B.A. with a minimum of 1-year post-degree laboratory, manufacturing, or quality control/assurance experience.
Chemistry, Biology, Microbiology, Biochemistry, or associated field.
Base level to ensure understanding of cGMPs, GLPs, Q7A and ICH guidance. Knowledge of general laboratory equipment; technical standards, principles, concepts, and techniques. Knowledge of compendia monographs testing such as USP, EP and JP.
• QCRM Specialist I: 1+ years of relevant experiences in a pharmaceutical development or quality control environment.
• Knowledge and understanding of cGMP, Q7A, ICH guidance and various compendia monographs.
• Ability to be flexible and understand risk
• Ability to recognize and implement continuous improvement
• Ability to conflict resolution; solid team player and able to function within team-based organization.
• Strong organizational and communication skills and attention to detail