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.

This position 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 trained and is compliant in Company Quality Standard Operating Procedures (SOPs), production SOPs as needed, and Systems Applications and Products (SAP) functions as required.

Learns and adheres to current Good Manufacturing Practices, the manufacturing process, our Company Quality Systems, and safety procedures.

Responding to environmental events that happen in classified areas and having flexibility to accommodate schedule changes as necessary to support 24 / 7 operations.

Authors, reviews, and approves routine and event-based environmental related documentation, reports, and / or data assessments, as warranted.

Schedules testing and works with operational areas independently to ensure work assignments are driven to closure. " Conducts Test site map updates and related project work " Performs change request tasks, as applicable " SOP updates and data management.

Reading, understanding and trending results " Actively participates in the Tier process and uses this forum to escalate concerns and best practices.

Partners with IPT members in the identification and implementation of continuous improvement initiatives and action plans.

As applicable, aides in the deviation management systems to address environmental excursions; this includes attending DM Tier meetings, working with operations to evaluate events, and shop floor presence for evaluation, in addition to other associated tasks.

Assists with training and coaching of incoming personnel. " Actively supports internal and regulatory inspections, as warranted.

Quals

Education : Bachelor's degree (firm) 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, TrackWise, 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.

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.

Last updated : 2024-05-20