Environmental Monitoring (EM) Specialist

Xseer Pharmaceuticals is hiring an Environmental Monitoring (EM) Specialist in Los Angeles, CA. The role involves routine and non-routine monitoring of classified manufacturing areas to ensure compliance with cGMP standards. Responsibilities include sampling, investigating deviations, maintaining records, and supporting audits. Candidates should have a Bachelor's degree in Microbiology or related fields and 2+ years of relevant experience. Strong knowledge of cGMP and environmental monitoring equipment is required.
Job Summary:
We are seeking a skilled and detail-oriented Environmental Monitoring (EM) Specialist to join our team Xseer Pharmaceuticals, a 503B compounding facility. The EM Specialist will be responsible for performing routine and non-routine environmental monitoring of classified manufacturing areas, ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory standards. This position involves conducting surface, viable air, non-viable air, and personnel sampling, as well as supporting investigations into deviations and out-of-specification (OOS) results. The ideal candidate will have strong technical expertise in environmental monitoring within a pharmaceutical manufacturing setting and a thorough understanding of cGMP requirements.

Key Responsibilities:
• Routine Environmental and Personnel Monitoring:
• Perform and document routine surface, viable air, non-viable air, and personnel sampling, including gown qualifications, in classified areas (ISO 5, 7, and 8) according in compliance with aseptic techniques and environmental control standards.
• Perform sampling of water systems and other utility systems as required.
• Deviation and OOS Investigation:
• Participate in the investigation of environmental monitoring deviations and OOS results.
• Perform root cause analysis and contribute to the development of corrective and preventive actions (CAPA).
• Plate Incubation and Reading:
• Incubate environmental monitoring plates according to standard procedures and defined incubation conditions.
• Perform colony counting and identification of microorganisms as needed.
• Documentation and Reporting:
• Maintain accurate and complete records of all environmental monitoring activities.
• Prepare and review EM data for periodic trend reports, regulatory submissions, and internal audits.
• Ensure data integrity and compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
• Compliance and Training:
• Ensure compliance with cGMP, FDA, and state regulations related to a 503B compounding facilities.
• Support internal and external audits by providing documentation and responding to audit observations.
• Provide training to new staff on environmental monitoring procedures and aseptic techniques.
• Complete daily room release and Quality Audit activities
• Other Responsibilities:
• Collaborate with the Quality Assurance and Manufacturing teams to maintain environmental control in the production environment.
• Support media fill trials and qualification activities as needed.
• Participate in continuous improvement initiatives to enhance EM processes and procedures.
• Support product acceptance and product release testing (endotoxin/sterility/particulate matter/growth promotion) under the supervision of the Sr. Microbiologist as required and when necessary

Qualifications:
• Bachelor’s degree in Microbiology, Biology, or a related field.
• 2+ years of experience in environmental monitoring within a pharmaceutical or 503B compounding environment.
• Strong knowledge of cGMP, FDA, USP <797>, <800>, and <1116> requirements.
• Experience with environmental monitoring equipment (e.g., particle counters, microbial air samplers, contact plates).
• Proficiency in aseptic techniques and cleanroom gowning procedures.
• Excellent analytical, organizational, and communication skills.
• Ability to work in a fast-paced, highly regulated environment with strong attention to detail.

Preferred Skills:
• Experience with non-viable (PMS) and viable (Lighthouse) equipment and software and electronic quality management systems (eQMS).
• Familiarity with microbiological identification techniques.
• Previous experience with media fill trials and cleanroom qualification.

Status: Salary, Exempt.

Job Type: Full-time

Pay: $79,000.00 - $87,000.00 per year

Benefits:
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:
• 8 hour shift

Work Location: In person