Quality Assurance Associate (GMP Certificate Program)

DESIRED QUALIFICATIONS:

• Must be able to work effectively in a fast-paced environment with cross-functional groups involved in multiple projects and timelines.
• Must be flexible in supporting changing priorities while maintaining a collaborative approach.
• Must be able to work independently with some supervision.
• Bachelor’s degree in Biology, Chemistry, or Life Science preferred.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor’s degree and one year relevant experience or an equivalent combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

·       Knowledge of GMP/ ISO compliance, and quality systems.

·       Applicable or related experience in a quality-related work in a cell therapy/biotech manufacturing setting

·       Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines

·       Experience with office software and database applications.

·       Excellent inter-personal skills and customer service focus.

·       Ability to communicate effectively both orally and in writing

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.