RTP EM Tech

Summary:

The QC Environmental Monitoring Technician will perform routine and investigational environmental monitoring of classified manufacturing, filling, and support areas. Support daily EM laboratory operations.

Responsibilities:

Support production operations by means of EM sampling of classified manufacturing, filling, and support areas and operations personnel.

Support daily EM laboratory operations and process/equipment qualification activities, as necessary.

Ensures compliance with current Good Manufacturing Practice (cGMP) and maintain constant inspection-readiness.

Ensures that data-integrity is maintained

Participate in process streamlining and continuous performance improvement.

Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

EM Technician requires gowning certification, and repeatedly aseptically gown daily.

Requirements:

High School Diploma or equivalent, Associates degree preferred.

Understanding of cGMP

Excellent written and oral communication skills and ability to collaborate and interact with a team.

Work in a dynamic and fast paced environment with potential to work shifts and weekends.

Must be able to lift 30 pounds and be able to pass, push, and pull to execute specific aspects of job duty.

Must be able to stand / walk for extended periods of time.

Preferred Qualifications:

Environmental Monitoring experience preferred.

Manufacturing or production experience preferred.

Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable.

Technical writing and written communication skills are a plus.

Understanding of regulatory standards / requirements for EM.

Knowledge of / familiarity with Parenteral production environments and operations.

Strong computer skills, documentation skills, and attention to detail.

Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.

Ability to focus on continuous improvement.

Previous experience with laboratory IT systems including LIMS, LES, and standalone COTS systems.

Understanding of compliance requirements and regulatory expectations for lab systems.

Additional Information:

Minimal travel required.

Some allergens are present in the parenteral plant.

12 hour shifts on 2-2-3 schedule, days or nights

Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Benefits & Perks:

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

JO-2412-156344