Address
Form of work ENVIRONMENTAL MONITORING QUALITY SPECIALIST
WEST POINT, PA
WEST POINT, PA
The pay ranges between $43 - $45.85 per hour.
Project Description:
- 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 products 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.
- 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.
Required Skills:
- 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 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 are 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.
- 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 a 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.
- Driven and can work in a fast-paced environment that encompasses meeting due dates of assignments on an ongoing basis.
- Collaborative, organized, capable of teamwork and independent work, which includes capability to comprehend and execute standard operating procedures.
- Attention to detail, capability to prioritize workstreams, and to focus are necessary skillsets to meet task assignments on weekly basis.
- Enjoy working in a dynamic operational environment and understand the importance of quality oversight.
- Adaptable, self-managed, efficient in accomplishing work responsibilities, can drive work to completion via networking and independently driving results.
- Have knowledge of writing technical documentation, familiar with project work.
- Familiarity with deviation management is a plus.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Krysty: krysty@alphaconsulting.com
ALPHA'S REQUIREMENT #24-00007
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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