Quality Control Technician
TSR is a premier national U.S. staffing company with over 50 years of staffing excellence.
Our client, a leading Pharmaceutical Company, is hiring a QC Technician on a long term contract basis.
Location: Warren, NJ (currently remote)
- The QC Technician is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.
Duties and Responsibilities:
- Perform testing of in-process, final product, and stability samples.
- Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
- Capable of handling complex issues and solving problems with only general guidance.
- Prepare and present continuous improvement projects to management.
- Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
- Complete all work in a timely manner.
- Perform peer review of testing data.
- Review all data in accordance with applicable procedures and cGMP requirements.
- Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
- Complete all reviews in accordance with required release timelines.
- Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
- Train new analysts to general job duties.
- Complete necessary training to become a qualified trainer.
- Perform training effectively.
- Document training per procedural and cGMP requirements.
- Support document revision, project, CAPA, and investigation/deviation tasks.
- Perform assigned tasks within a CAPA, deviation, or project.
- Participate in complex projects and continuous improvement efforts.
- Take a leadership role, as required, for projects.
- Draft and review technical documents, such as SOPs and protocols/reports.
- Communicate effectively with management regarding task completion, roadblocks, and needs.
- Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.
- Performs other tasks as assigned.
- 4-7 years of relevant work experience, preferably in a GMP regulated environment.
- Advanced hands-on experience with various analytical techniques including but not limited to ELISA, qPCR, Flow Cytometry and scientific knowledge in the characterization and transfer of pharmaceutical products.
- Advanced ability to accurately and completely understand, follow, interpret and apply Health authority Regulatory and cGMP requirements.
- Advanced technical writing skills.
- Advanced problem-solving ability/mentality, technically adept and logical.
- Ability to represent the interests of the group on cross-functional teams.
- Ability to set priorities of the group and manage timelines.
- Advanced ability to communicate effectively with peers, department management and cross-functional peers.
- Bachelor’s degree required, preferably in Science; Advanced Degree preferred.
- The incumbent will be working a laboratory setting up to six (6) hours per day.
- The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.