Environmental Monitoring Sampling Technician
1 Antibody Way, OCN351 Oceanside, CA 92056
Bayside Solutions is seeking Environmental Monitoring Sampling Technician to be part of our client’ s team in Oceanside. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Environmental Monitoring Sampling Technician
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Activities include collecting and transporting Environmental Monitoring samples that are collected in facility.
- The areas where the samples are to be collected are identified as Laboratory Information Management System (" LIMS") Environmental Monitoring (" EM") routes for the manufacturing department.
- In addition, performing the sanitization of materials and equipment that is moved into the facility.
- Good Manufacturing Processes (" GMP") classified areas through Airlock 1014 and Airlock 1018.
- Collect Room EM samples for EM routes that are assigned to downstream manufacturing.
- Collect at frequency specified by site procedure.Transport to predefined designated area.
- Maintain inventory of sample collection material, i.e. media, equipment, IPA, etc.
- Monitor the calibration of sampling equipment and coordinate the calibration activity with ISG.
- Maintain, inspect, and monitor Genentech provided EM sampling equipment to ensure it remains fit for use.
- Store Genentech provided EM sampling equipment at Genentech designated storage locations.
- Distribute EM sampling training materials to necessary personnel, maintain training of collectors and managers pursuant to Genentech training requirements and utilizing Genentech provided training resources.
- Develop and manage EM sampling schedule specifically for downstream manufacturing.
- Perform post Over Action Limit (" OAL") EM sampling for the specified areas.
- Perform non-routine sampling, i.e., Return to Service Qualification (" RSQ"), Adverse event investigation/remediation for the specified areas.
- Complete TrackWise assignments related to OALs and adverse events i.e. procedural variances.
- Cleaning Assessments
- Training Assessments
- Report ongoing activities at time of sample collection, i .e. maintenance, repairs, etc.
- Apply sanitizer to the external surfaces of materials and equipment that is to be moved across the demarcation lines in Airlock 1014 and Airlock 1018 per site procedures .
- Remove the items from the airlocks to a designated holding area where the items will be collected by the user.
- Schedule periodic material transfer in order to prevent the accumulation of items in the airlocks.
- Notify the user when items are ready to be removed from the holding area.
- Must have at least a HS diploma.
- Job entails setting up EM equipment in various locations to test for viable and nonviable air samples utilizing two testing units.
- The technician also takes surface samples with agar plates, and labels them all appropriately utilizing the LIMS system software.
- They submit the samples to QC for testing.
- Worker will walk up mezzanine stairs to take surface samples or use an extending rod for ceiling samples.