The Quality Assurance Specialist is responsible for supporting the development, implementation and administration of the Quality Assurance Program. The incumbent actively supports and complies with all ATCC corporate and departmental policies and procedures.
- Understand the goals and objectives of the organization; communicates, develops, motivates, and assists with staff training, as necessary, to help achieve the company’s Quality goals.
- Assists with development of standard operating procedures applicable to Quality System Regulations.
- Assists with the administration of corrective and preventive action in accordance with standard operating procedures.
- Advises internal customers to ensure ISO compliance with product development goals according to company SOPs.
- Functions as a lead auditor in assisting with both internal audits and vendor audits to ensure compliance to documented procedures. Supports the department with resolution and monitoring of any identified action items.
- Assists with the preparation of data for management reviews. Assists with the implementation of any resultant action items.
- Assists with the issuance, control, receipt, and maintenance of lab books.
- Assists with training staff in accordance with quality-related policies and procedures as requested.
- Performs other ancillary duties as assigned.
Education and Experience:
- A Bachelor’s Degree is required; a degree in a biological field, chemical sciences or related discipline is preferred but not required.
- 3 to 5 years experience in field of quality assurance is required.
- Experience with ISO, GXP or other quality systems preferred.
- Good computer skills are required.
Knowledge, Skills and Abilities:
- Excellent interpersonal and communications skills
- Excellent organization and analytical skills
- Ability to work alone or within a team environment
- Ability to foster high degree of customer satisfaction
- Perform other duties as assigned.
Founded in 1925, ATCC is a non-profit organization with a mission to acquire, authenticate, preserve, develop, standardize, and distribute biological materials and information for the advancement and application of scientific knowledge.
ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.