Quality Assurance Specialist

DESIRED QUALIFICATIONS:

• Bachelor’s degree in life sciences (e.g. biology, chemistry, etc.).
• Ability to effectively work in fast pace environment with cross functional groups involved in multiple projects and timelines.
• Flexibility to support changing priorities while maintaining collaborative approach.
• Able to work independently with some supervision.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor’s degree and three years relevant experience or an equivalent combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

·       Working knowledge of GMP/ ISO compliance and quality systems.

·       Working knowledge of federal, state and local regulations, GMP, IND, FDA, and CMC.

·       Demonstrated ability of problem-detection and problem-resolution skills.

·       Demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.

·       Must possess excellent verbal and written communication skills

CERTIFICATIONS & LICENSES:

None

PHYSICAL REQUIREMENTS*:

• Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of the job.

WORKING CONDITIONS:

·       Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.

·       May require working in close proximity to blood borne pathogens.

·       May at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.

·       May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/Chemicals, confined spaces, working at heights

·       May require extended or unusual work hours based on research requirements and business needs.