QC Biochemistry Analyst

QC Biochemistry Analyst

  Not Disclosed

  Durham , NC

  6.5 Months

  Not Disclosed

  Not Disclosed

  Pharmaceutical

Job Description

Description :

QC Biochemistry Analyst 1 (Nights/Rotating Schedule)

Position Summary:

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.
Investigational writing.

Responsibilities:

1. Quality

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.
Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
Prepares for regulatory, customer, and internal audits of Biochemistry laboratory areas.
Preparation includes review of logbooks, instrument calibration dates, material expirations, and general cleanliness of laboratory area.
Executes laboratory investigations as assigned by management in compliance with procedures.
Provides input for laboratory investigations and documents invalid test results in compliance with procedures.


2. Documentation/Training

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.

3. Safety

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

4. Continuous Improvement

Participate in continuous improvement activities.

6S: Maintain the laboratory and other specific testing areas of responsibility in a well organized, clean, and tidy manner in compliance with cGLP.

5. Other Duties

Performs additional job related duties as assigned by management.

Supplemental Information:

This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. . The QC Biochemistry Analyst 1 will be in a key position in the Biochemistry laboratory performing testing of Description, pH, FTIR, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC.

Training and Education:

BS/BA in Biology, Chemistry, or Biochemistry with 0 years of relevant experience preferred.

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.

Knowledge, Skill, and Abilities:

Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.
Excellent and effective verbal and written communication skills.
Ability to problem solve/troubleshoot and provide solutions under minimal supervision.
Good communication skills; Teamwork orientation.
Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.
Able to assess safety and environmental risks to ensuring tasks adhere to HSE Management System.

Note :

7p-7:30a on a rotating 2-2-3 (two days on, two days off, three days on)
Temp to hire possibility
Hours Per Day12
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status