6303 QC Analyst I

Job Description:
Perform Analytical Chemical testing of drug substances and drug products for release or stability
programs.
Perform laboratory testing in a cGMP environment and understand the science and compliance needs of the business.
Actively participate in continuous improvement to maintain the company’s right to operate, supply to patients, and cost-effectiveness.

Job Responsibilities:
Leadership:
Create an environment of strong team spirit with timely and effective communications.
Develop the ability to influence using technical and personal reasoning.

Technical:
Perform a broad variety of basic and moderately complex tests in support of lab operations.
Perform testing of a routine and non-routine samples and documents according to cGMPs.
Perform routine lab maintenance.
Prepare basic and complex reagents as assigned.
Order and maintain lab supply inventory.
Aliquot samples as required, including aseptic aliquoting.
Receive and provide training.
Participate in assay transfer and assay validation.
Perform equipment qualification/maintenance.
Coordinate with customers to support operational activities.
Identify and support resolution of technical problems.
Actively participate in group and project teamwork; project and process improvements.
Resolve issues as needed with management approval.
Adhere to cGMP policies and procedures, including documentation activities.
Meets scheduled performance of 95% on time.
Perform other duties as requested by supervisor/manager to support Quality.

Education:
B.S./B.A. (preferably in relevant scientific discipline) or an equivalent combination of
education and experience.

Knowledge/Skills/Competencies:
Basic knowledge of scientific theories, principles, and techniques used in analytical or
biological test procedures.
Ability to exercise sound judgment, reasoning, and problem-solving.
Capable of completing assigned responsibilities and keeping manager informed of status.
Extensive knowledge and technical understanding to complete routine and non-routine assignments.
Good verbal and written communication skills are needed to accomplish assigned tasks.
Ability to work under minimal supervision to complete assigned tasks in a timely manner.

Work Environment/Physical Demands/Safety Considerations:
Work Environment:
The majority of work is completed at the location of employment in a laboratory type
setting.

Physical Demands:
Ability to make repetitive motions and manual manipulations of samples.
Must be able to lift 25 pounds.

Safety Considerations:
Work is performed in a laboratory setting. Exposure to hazardous chemicals may occur.
Work requires the use of glassware, needles, syringes, and hot plates. PPE (e.g. lab coat, safety
glasses) is required whenever working in the laboratory.

PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.