EM Specialist, Quality

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Environmental Monitoring Specialist (EM Specialist) provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model.  The EM Quality Specialist, with guidance from the EM Lead, ensures product / process quality and performs activities to facilitate the release of product to the marketplace.  The EM Quality Specialist is responsible for the review and evaluation of routine and per process environmental monitoring (EM) sampling of classified areas and utilities.  This position also works closely with the assigned End to End (E2E) in a team environment to ensure timely completion of responsibilities with emphasis on right first time. 

The EM Quality Specialist will become knowledgeable in Federal and other regulatory agency requirements and GMPs to assure that all areas operate in a state of compliance, and will train on and gain competency in their responsibilities for assigned End to End (E2E).  Specific responsibilities include but are not limited to the following:

Becomes fully trained in our Company Quality SOPs, production SOPs as needed, and SAP functions as required by EM Quality Specialists.

Basic Functions & Responsibility Essential function(s) includes, but is not limited to:

• Learns cGMPs, the manufacturing process, and our Company quality systems.

• Monitor environmental performance against specifications within classified areas.

• Provide environmental support to manufacturing and testing areas as needed.

• Performs Quality review/approval of new and updated SOPs and Controlled Job Aids.

• Ensures compliance with departmental procedures.

• Actively participates in the Tier process and uses this forum to escalate concerns and best practices.

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

• Adherence to SOPs, GMPs and safety procedures.

• Aid in investigations into environmental excursions.

• Author environmental project protocols and reports.

• Assists with training of incoming personnel.

Education Minimum Requirement:

• Bachelors Degree

Job functions are performed primarily on the production shop floor or at desk and in a team environment.

Cross trains to support other functional quality areas including but not limited to deviation management for environmental monitoring investigations, and inspection support. Supports Process Simulations as a Quality Aseptic Observer.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights