Quality Specialist - EMS

Environmental Monitoring Quality Specialist

Location:

770 Sumneytown Pike, West Point, PA Pay Rate: $45/Hr

Qualifications:

• Education:
  
  Bachelor's degree in Microbiology, Biology, Chemistry, Technology, or other related scientific areas of study.
• Minimum of 5 years of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing, or Microbiological Laboratory Operations or related industry experience in technology, manufacturing, science related setting.
• Understanding and experience working in deviation management for testing results and other related deviations.
• Must have experience working within cGMP classified environments, have been involved with shop floor programs, and are proficient in understanding of pharmaceutical regulations.
• It is necessary to have experience with systems such as Comet/SAP, Midas, Track Wise, GLIMS, SQL LIMS, other quality systems, and Veeva Vault Quality Docs, Excel, Microsoft.
• Use of leadership skillsets to drive work assignments to completion to meet rigorous due dates is necessary, proficient oral and excellent written communication skillsets is necessary to accomplish work assignments.
• Proficiency in demonstration of analytical and critical thinking skills are necessary and must be able to independently troubleshoot and resolve issues identified as part of assignments.
• Proficiency in working with and authoring GMP documentation is necessary for assignments.
• Must have skillsets that enable great attention to detail.
• Need ability to have flexible schedule to accommodate 24/7 operations as needed.
• Proficiency in effective and inclusive interpersonal skills that include collaboration and ability to work in team environment and independently.
• Demonstrated ability to work independently throughout training and work assignments.
• Proficiency in training and coaching others on aseptic and related processes.

About You – You are driven and can work in a fast paced environment that encompasses meeting due dates of assignments on ongoing basis. You are collaborative, organized, capable of teamwork and independent work, which includes capability to comprehend and execute standard operating procedures. Attention to detail, capability to prioritize work streams, and to focus are necessary skillsets to meet task assignments on weekly basis.

You enjoy working in a dynamic operational environment and understand the importance of quality oversight. You are adaptable, self-managed, efficient in your accomplishing work responsibilities, can drive work to completion via networking and independently driving results. You have knowledge of writing technical documentation, familiar with project work. Familiarity with deviation management a plus.

Responsibilities:

The Environmental Monitoring (EM) Quality Specialist provides direct Quality support to the production area as part of a Quality Integrated Production Team (IPT) Operating model. With guidance from the Integrated Production Team Quality Leadership team, the Environmental Monitoring Quality Specialist will ensure product / process quality and perform activities to facilitate the release of product to the marketplace. The Environmental Monitoring Quality specialist is accountable for the following tasks, as requested:

• Review and evaluation of routine environmental monitoring sampling of classified areas and utilities.
• Works closely with the assigned End to End (E2E) operational and deviation management (DM) representatives in a team environment to ensure timely completion of duties with emphasis on right first time and ensuring assignments on completed ahead of assigned due dates on weekly basis.
• Job functions are conducted in classified production areas requiring experience in cGMP environments. Additionally, the job is conducted within an office setting.
• The Environmental Monitoring Quality Specialist is to be experienced in federal and other regulatory agency requirements and GMP (Good Manufacturing Practices) to assure that all areas operate in a state of compliance; independent and instructor led training is ongoing to gain competency.
• Specific responsibilities include but are not limited to the following:
• Becomes fully…