Rep Quality Assurance - Eso- Marlborough, Massachusetts - Monday to Friday
- Coordinates Quality Assurance activities in the assigned testing department.
- Supports compliance with required regulatory processes in accordance with company policy, state and federal requirements.
- Supports inspection readiness at all times.
Essential Job Duties and Responsibilities
- Supports compliance with all applicable regulatory agencies and company policies.
- Coordinates compliance with applicable regulations through documentation, audits, and corrective action.
- Performs preliminary review of all departmental quality records. Collaborates with management in the testing department to investigate and help resolve non-conformances.
- Audits the training and competency program for assigned testing department. Provides training for staff in assigned department for Quality Assurances policies and procedures.
- Coordinates departmental internal and external proficiency testing activities.
- Supports compliance with document control policies for all procedures and related documents used in the assigned testing department’s quality program.
- Assists with internal and external audits. Performs audits in assigned department and other departments as directed.
- Promotes continuous quality improvement by collaborating with management to implement standardization and process improvement.
- Performs special projects as assigned.
- Actively participates as a member of the Quality Improvement Team.
Experience, Education, and Licensure
- At least 6 years of progressive laboratory experience.
- Bachelor's degree in medical technology or other life or physical sciences from an accredited college or university.
- ASCP certification or eligible preferred.
Knowledge, Skills and Abilities
- Demonstrates knowledge of current company policies and procedures.
- Demonstrates knowledge of current local, state and federal requirements.
- Demonstrates leadership skills through accountability, integrity, and collaboration in daily tasks.
- Demonstrates initiative and strong problem solving skills.
- Communicates with employees in a manner that creates an informed, positive environment.
- Facilitates efforts to work with others in a way that promotes teamwork and change.
- Projects a positive, professional demeanor.
- Proficiency in computer skills using Windows based software (Word, Excel, etc.). Other computer skills such as statistical analysis and laboratory information system helpful.