QUALITY SPECIALIST l

Job Description

Job Description

Position Description : SUMMARY : Nvision seeks a highly motivated Quality Assurance Specialist I to join our team. The successful candidate will be responsible for ensuring compliance with all regulatory and quality requirements in our organization.

DUTIES AND RESPONSIBILITIES :

Review and approve product batch records, labels, and certificates of analysis

Conduct investigations of non-conforming materials or products

Participate in quality audits, and implement corrective actions where necessary

Conduct internal audits of quality systems

Maintain records of quality assurance activities and prepare reports for management review

Participate in quality improvement projects and initiatives

May perform other duties and responsibilities as assigned or directed

SUPERVISORY RESPONSIBILITIES :

This job has no supervisory responsibilities.

QUALIFICATIONS :

Knowledge of FDA regulations and ISO standards

Experience with document control and record keeping

Strong attention to detail and analytical skills

Excellent written and verbal communication skills

COMPETENCIES :

Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce

Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values

Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan

Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed

Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals

Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity

Planning / Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans

Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions

Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed

Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others

Education and Experience :

Bachelor's degree in biology, chemistry, or related field

1-2 years of experience in a quality assurance role in a regulated industry

PHYSICAL DEMANDS AND WORK ENVIRONMENT :

Frequently required to stand

Continually required to walk

Occasionally required to sit

Ability to lift up to 50 pounds

Frequently required to talk or hear

Occasional exposure to bloodborne and airborne pathogens or infectious materials along with occasional exposure to cadaveric specimens

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.