Data Analyst/Auditor

Data Analyst/Auditor

Data Analyst/Auditor


Job Type: Full-Time
Location: St. Paul , MN






Job Description:

MEMORIAL BLOOD CENTERS
POSITION DESCRIPTION

TITLE: DATA ANALYST/ QUALITY AUDITOR


Department: Quality and Regulatory Affairs
Reports To: Director, Quality & Regulatory Affairs
FLSA Status: Exempt

PRIMARY PURPOSE:

. To develop data analysis processes under the direction of the Director of Quality and Regulatory Affairs, to support the Blood Center's quality goals.
. To perform quality assurance functions under the direction of the Director of Quality and Regulatory Affairs, in accordance with FDA, AABB, CLIA and other regulatory and/or accrediting agencies.
. To support the organization in the development, maintenance and monitoring of measurements relating to quality and work systems, as well as performance improvement activities.
. To lead and support continuous performance improvement initiatives within the blood center that affect the standardization of work systems, organizational productivity, efficiency and profitability, or customer satisfaction utilizing Lean/Six Sigma, traditional problem solving or Plan-Do-Check-Act methodologies.
. This position develops and performs quality assurance audits to ensure compliance to standards and regulations and analyzes quality data to determine opportunities for improvement and to evaluate the effectiveness of changes.
. To assure that the entire organization is in compliance with Federal and State regulations and AABB Standards regarding blood and tissue establishments and blood center laboratories by conducting audits.

DUTIES AND RESPONSIBILITIES:

1. Facilitates the development and management of measurements for operating and quality systems and for performance improvement activities. Creates quality reports as needed.

2. Perform data evaluation to ensure systems are functioning as expected. Identify adverse trends and work with system owner in root cause analysis and the implementation of effective corrective and preventive actions.

3. Participates in ongoing performance improvement activities working with interdepartmental or departmental teams.

4. Assists departments with tracking and trending results that align with organizational goals.

5. Conduct audits of critical factors as needed to assure compliance with applicable policies and procedures including the follow-up on findings.

6. Responsible for maintaining knowledge of current regulations and standards, and for the implementation, enforcement and monitoring of compliance to these regulations and standards.

7. Provide information and support to operations departments on issues related to FDA biologic and drug regulations, current good manufacturing practices (cGMP), AABB Standards and other regulatory and/or accreditation requirements (CLIA, OSHA, MDH, FACT, etc.) including the follow-up with operational departments on inspection findings.

8. Maintains current and accurate records of all relevant communication and a required documentation.

9. Other duties as assigned.


REQUIREMENTS:

Training and Education: Bachelors degree
ASQ certification preferred

Skills and Abilities: High attention to details and follow-through.

Excellent written and verbal skills and the ability to affect desired results in a varied environment of changing priorities.

Exceptional interpersonal skills.

Must be able to work independently and make accurate, independent decisions.


Experience: Proficient with Crystal reports, Microsoft Word and Excel required. Experience with web-based system and databases preferred.

Experience working in a regulated environment preferred.

2-6 years work experience performing data analysis desired.


Experience in statistical process control desired.

Experience in facilitation of process improvement activities including the use of methodologies such as Six Sigma, Lean, Root Cause analysis preferred.


Supervision: May provide direction to organizational leaders related to data.

Requires minimal supervision by Director


We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.