Quality - Quality Control Technician

TechDigital Group; Harvard (MA); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading company is seeking a QC Analyst to support Quality Control analytical testing of incoming raw materials. The role requires a Bachelor's degree in Science and 0-2 years of experience, with a focus on various bioanalytical techniques. As a vital part of the team, the QC Analyst will perform tests, troubleshoot issues, and ensure compliance with cGMP requirements while working in a laboratory setting.

Qualifications

• 0-2 years of relevant work experience in a regulated environment.
• Hands-on experience with bioanalytical techniques.
• Ability to follow and apply Global Regulatory and cGMP requirements.

Responsibilities

• Perform testing of incoming Raw Materials.
• Utilize analytical testing methods and laboratory equipment.
• Complete work in a timely manner and communicate effectively within the team.

Skills

Problem-solving ability

Technical aptitude

Effective communication

Education

Bachelor's degree in Science

Tools

HPLC

UPLC

ELISA

qPCR

FACS

Job description

100% Onsite- 1st Shift!

The QC Analyst is responsible for supporting Quality Control analytical testing of Incoming Raw Materials. This includes in house testing and sending out samples to contract testing labs. Some of the testing methods performed in house are HPLC/UPLC, Conductivity, OSMO, Titration, Melting Point and various other techniques.

Education:
Bachelor's degree required, preferably in Science.
• 0-2 years of relevant work experience, preferably in a regulated environment.
• An equivalent combination of education and experience may substitute.


Experience:
• 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.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to set priorities and manage timelines.
• Ability to work with management.
• Ability to communicate effectively with peers, department management and cross-functional peers.

DUTIES AND RESPONSIBILITIES:

• Perform testing of incoming Raw Materials.
• Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
• Anticipate and troubleshoot problems.
• Complete all work in a timely manner.
• Work and communicate effectively within the teamto 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.
• Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
• Document training per procedural and cGMP requirements.
• Support document revision, project, CAPA, and investigation/deviation related tasks.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Performs other tasks as assigned.

WORKING CONDITIONS (US Only):
• The incumbent must analyze numerical values on a daily basis.
• The incumbent will be working a laboratory setting.
• The incumbent will be working around biohazardous materials, including chemical agents.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.