Quality - Quality -Data Analyst
Company: Omni Inclusive
Location: Summit
Posted on: April 24, 2024
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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:
Must have knowledge and experience with cGMP manufacturing,
Quality, and compliance.
Must have experience with Deviations, Root Cause Analysis, and
CAPAs.
Must have knowledge of data trending and tracking, including use of
statistical analysis software a plus.
Proficient in Excel data mining and report creation.
Ability to use electronic Quality systems such as Infinity.
Junior to intermediate ability to interpret results and situations
and articulate recommendations for resolution.
Knowledge of US and global cGMP requirements.
Excellent verbal and written communication skills.
Requires moderate direction to complete more complex tasks;
completes routine tasks with little or no supervision.
Work is self-directed.
Confident in making decisions for non-routine issues.
Able to prepare written communications and communicate problems to
management with clarity and accuracy.
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:
Responsible for trending of deviations at S12.
Facilitates Trending Governance meetings. Issues minutes and
notifies senior leadership of any risks or delays.
Reviews all deviations and notifies management of any trends.
Must have ability to author reports, interpret results, and
generate conclusions consistent with Quality risk management
principles.
Knowledge of quality processes, including investigations, and CAPA
management.
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.
Keywords: Omni Inclusive, Philadelphia , Quality - Quality -Data Analyst, Professions , Summit, Pennsylvania
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