Quality Control Technician

About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee's voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Quality Control Technician

Job Description

• Location: Summit, New Jersey
• Type: Contract
• Job #80381

Our client, a leading pharmaceutical company, is hiring a Quality Control Technician, on a contract basis.

Job ID #: 80381

Work Location:
Summit, NJ - 100% Onsite

Summary:
The QC Analyst 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.

Education/Experience:

• Bachelors degree required, preferably in Science.
• 2 years of relevant work experience, preferably in a regulated environment.
• An equivalent combination of education and experience may substitute.
• Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS.
• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Technical writing skills.
• 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.
• Ability to work with management locally and globally.
• Ability to communicate effectively with peers, department management and cross-functional peers.

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.
• Anticipate and troubleshoot problems.
• Recommend corrective actions and participate in the development of best practices.
• 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.
• Work and communicate effectively within the team to ensure timelines are met.
• 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 review 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 related tasks.
• Perform assigned tasks within a CAPA, deviation, or project
• 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.