QC Biochemistry Analyst

Position: QC Biochemistry Analyst 1
Job Title:

QC Biochemistry Analyst 1

Onsite

Employment Type: 6+ months contract

location:
Durham, NC

JOB DESCRIPTION

QC Biochemistry Analyst 1 (Nights/Rotating Schedule)

7p-7:30a on a rotating 2-2-3 (two days on, two days off, three days on)

$22-$23/hr + 15% shift differential

Temp-to-hire possibility

The QC Biochemistry Analyst 1 role is responsible for routine Biochemistry testing. The responsibilities of this position include:

• Testing of raw materials, intermediates, special test requests, stability, and finished product per standard operating procedures.

• Investigation writing.

Responsibilities:-Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.

-Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner.

-Prepares for regulatory, customer, and internal audits of Biochemistry laboratory areas.

-Preparation includes review of logbooks, instrument calibration dates, material expiration, and general cleanliness of laboratory area.

-Executes laboratory investigations as assigned by management in compliance with procedures.

-Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.

-Ensures personal training is maintained to current department processes and procedures.

-Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.

-Participate in continuous improvement activities.

Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner in compliance with cGLP.

Training and

Education:



BS/BA in Biology, Chemistry, or Biochemistry

A high school diploma/GED with a minimum of 4 years of progressively responsible experience working in a regulated laboratory environment, GMP preferred and/or an

Associate's Degree with a minimum of 2 years of progressively responsible experience working in a regulated laboratory environment, GMP environment.

Experience:

Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP) preferred.

Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills preferred.

Experience with microbiological testing, sterility and aseptic technique, knowledge of USP and EP/BP method/validation regulations preferred.