(EM – Water Sampling/Investigations Protocol Support) At client, we are deeply connected by our mission. No matter your role at client, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Client’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. What you'll be doing • Collect environmental monitoring samples throughout the facility following Standard Operating Procedures on a defined frequency • Collect water samples throughout the facility on a daily/weekly/monthly basis • Process water samples for testing of Microbial Total Count and Coliform • Be able to climb ladders/scaffolding for water sampling purposes • Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in clean rooms • Reviews Environmental Events/Deviations to ensure documentation and testing is complete prior to submitting for approval • Develops joint relationships with Quality Operations/ Manufacturing/Engineering to initiate corrective actions/work orders when issues are identified on the floor • Leads the investigation of microbial out of limits that occur in operations and is responsible for conducting the investigation, determining root cause, and defining effective corrective and/or preventive actions to prevent recurrence • Partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause, and CAPAs • Interacts with all levels of staff and provides timely updates on investigation status • Fosters collaborative relationships focused on high-quality and timely investigations, effective corrective actions and the reduction of out-of-limit generation rate • Closes investigations in a timely manner to meet business and compliance needs • Works with minimal supervision to drive investigations to closure • Manages several investigations at a time • Complete testing within required timeframes • Validation Protocol coordination with the Technical Services and Microbiology Group • Sustain a clean and safe work environment applying 6S principles What you'll bring • B.S. degree in Microbiology, Biology, or related science • 0-2 years of experience; minimum 1 year experience in Pharmaceutical/Medical Device industry preferred • Experience in conducting root cause investigations in the pharmaceutical/medical products industry preferred. • Strong communication and project management skills • Possess knowledge of core manufacturing and support systems • Computer literate/knowledge of Microsoft office applications (Word, Excel) • Must have good interpersonal skills and able to work optimally and efficiently in a team-based environment • Proficient in the aseptic use and handling of media plates and swabs for EM sampling • Must be a dedicated individual who requires minimal direction • Attention to detail and strong organizational skills • Must have a basic understanding of laboratory instrumentation • Good documentation skills and knowledge of GDPs (Good Documentation Practices) • Able to manage multiple tasks/priorities in a timely manner • Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology • Familiarity with LIMS (or equivalent system) and TrackWise • Able to communicate optimally with supervisors and peers • Knowledge of FDA quality system regulations is preferred
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $22.00/hr.
