Summit,
NJ
07901
US
Posted: 09/06/2023
2023-09-06
2023-10-31
Job Number: 24910970
Job Description
QUALITY SYSTEM SPECIALIST
SUMMIT, NJ
This Position requires 50% on site or more as needed.
- Minimum qualification is Associate's degree required.
- 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.
The pay ranges between $40.00 to $43.06 per hour.
Required Skills:
- Associate degree or higher required, minimum of three years of experience in the pharmaceutical or related industry; equivalent combination of education and experience acceptable.
- 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.
- Must have ability to author reports, interpret results, and generate conclusions consistent with Quality risk management principles.
- 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.
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.
Project Description:
- The Quality System Specialist 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.
- 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.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: cindi@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-01487
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
#LI-DNI
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