You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

The Environmental Monitoring (EM) Technician plays a crucial role in ensuring compliance with environmental standards by conducting routine and batch-related environmental monitoring within cleanroom settings and other controlled environments. This position operates under the guidance of the Quality Control Manager and aligns with current Good Manufacturing Practices.

Key Responsibilities

• Perform thorough Environmental Monitoring (EM) in aseptic environments, including gowning monitoring and utilities testing.
• Conduct Daily, Weekly, Monthly, and Quarterly EM tasks, such as viable air, non-viable particle counts, and contact surface testing.
• Maintain comprehensive and real-time documentation in GMP documents.
• Ensure reliable data integrity and accurate recording, review, and storage of laboratory data.
• Support EM lab operations, including setup and daily activities, incubation and enumeration of organisms, and preparation for shipping to contract laboratories.
• Provide EM support in the review and tracking of microbiology results for product release.
• Assist with facility qualification and validation and maintain equipment functionality through proper calibration, maintenance, and troubleshooting.
• Engage in hazardous waste training and management and seek continuous improvement within EM-related activities.
• Collaborate with Quality Assurance to ensure timely completion and data review of microbiological data.
• Comply with regulatory requirements and company standards, such as the US Food, Drug & Cosmetic Act and Well’s Pharma's Core Values.

Qualifications

• Knowledge of cGMP regulations and FDA CFR Title 21 parts 210 and 211.
• Strong verbal, written communication, and computer skills are required.
• Proficiency in Microsoft Excel is highly desirable.
• Understanding of laboratory science and aseptic techniques principles.
• Ability to work independently and cooperatively as part of a team.

Experience

• Minimum of 1 year of experience in the pharmaceutical and biopharmaceutical industry.

Additional Requirements

• Work is conducted in a laboratory and cleanroom setting with exposure to bio-hazardous materials, hazardous waste, and pharmaceuticals.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

^*As a job position within our Life Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk work environments (warehouse or industrial areas), high-risk/ high-error job duties that could result in life-threatening injury or death, operation of heavy-duty machinery, working with hazardous chemicals, exposure to other dangerous materials, such as drugs and sharp instruments. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.