Job Description

50% onsite

PURPOSE AND SCOPE OF POSITION:

The DM analyst is responsible for evaluating Deviations to identify patterns and trends, monitor trend investigations E2E including CAPAs and EC to eliminate trends, perform analysis of deviation data and summarize information for Annual Product Quality Review and other required reports. Notification to management of identified trends.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

1. Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
2. Must have experience with Deviations, Root Cause Analysis, and CAPAs.
3. Must have knowledge of data trending and tracking, including use of statistical analysis software a plus.
4. Proficient in Excel data mining and report creation.
5. Ability to use electronic Quality systems such as Infinity.
6. Junior to intermediate ability to interpret results and situations and articulate recommendations for resolution.
7. Knowledge of US and global cGMP requirements.
8. Excellent verbal and written communication skills.
9. Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
10. Work is self-directed.
11. Confident in making decisions for non-routine issues.
12. Able to prepare written communications and communicate problems to management with clarity and accuracy.
13. Able to effectively multi-task.

Education and Experience:

Associate degree or higher required, minimum of three years of experience in the pharmaceutical or related industry. Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:

1. Responsible for trending of deviations at S12.
2. Facilitates Trending Governance meetings. Issues minutes and notifies senior leadership of any risks or delays.
3. Reviews all deviations and notifies management of any trends.
4. Must have ability to author reports, interpret results, and generate conclusions consistent with Quality risk management principles.
5. Knowledge of quality processes, including investigations, and CAPA management.
6. Able to effectively multi-task.

WORKING CONDITIONS (US Only):

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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