Lead Sterile Manufacturing Operator

2 months ago

Los Angeles, United States Xseer Pharmaceuticals Full time
Job DescriptionJob Description

Position Summary
Duties And Responsibilities

The Lead Sterile Manufacturing Operator (SMO) is responsible for overseeing, and
executing where needed, all processes related to the manufacture of sterile product at
Xseer’s 503B facility. Manufacturing personnel must adhere to 21 CFR parts 210/211
and USP / regulations, current Good Manufacturing Practices (cGMP), and
department’s Standard Operating Procedures (SOPs).
Performs sterile manufacturing in a cGMP cleanroom environment (ISO 5, ISO 7, ISO 8).
Manufactures sterile products accurately and in compliance with master batch records
while adhering to department specific SOPs.
Utilizes and coaches team on appropriate aseptic technique when performing tasks
within the cleanroom.
Operates all fill-finish and ancillary manufacturing equipment in order to deliver
quality medication.
Maintains an ISO classified environment through rigorous cleaning and disinfecting of
the cleanroom in accordance with approved procedures.
Adheres to, and completes, standard work documents, ensuring designated shift
personnel understand and achieve daily target goals.
Assists with sterilization of components used in the manufacturing process.
Performs/reviews essential calculations and completes thorough documentation.
Completes final review of cGMP documentation.
Methodically prepares work area and supplies prior to manufacturing.
Performs transfer of products from the cleanroom to the Inspection and Labeling team.
Performs ancillary tasks and duties that support the manufacturing process such as, but
not limited to, autoclaving, bubble point testing, material preparation, inventory
accounting, organization of components, and various LEAN manufacturing tasks (6S,
GEMBA, Kaizen).
Assists Sterile Manufacturing Manager with task delegation and completing shift reports.
Ensures all required hygienic practices and garbing are performed per company policy.
Observes and aids in coaching new hires on sterile operations.
Is dependable with attendance and is on-time for each shift start.
Provides overtime leadership support, as needed, to maintain appropriate inventory
levels.
Assist with special projects, as needed.
To perform this job successfully, an individual must be able to perform each essential
function satisfactorily. The requirements listed above are representative of the knowledge,
skill, and/or ability required. Reasonable accommodations may be made to enable qualified
individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear.
The employee is often required to remain in a stationary position for a significant amount of
the workday and frequently use their hands and fingers to handle or feel in order to access,
input, and retrieve information from the computer and other office productivity devices. The
employee is regularly required to move about the office and around the corporate
campus. The employee is occasionally required to stand, walk, reach with arms and hands,
climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job

Lead Sterile Manufacturing Operator
include close vision. Employee must be able to stand and walk for extended periods of time
for consecutive days. Employee must be able to lift up to 30 lbs.
Knowledge And Skills
Must be trained and qualified in the sterile operation via internal training program.

Experience And Qualifications
  
Must be Gown Qualified, permitting entry into the cleanroom.
Detail-oriented and self-motivated.
Work in a confined, controlled environment for extended periods of time (4 plus hours).
Must be able to fully gown in aseptic garb for extended periods of time.
Must be able to work with hazardous substances (drugs) and work with strong odors
(such as, but not limited to, peracetic acid).
Communicate and collaborate effectively with a team to achieve goals around safety,
quality, and delivery.
Ability to carry out and/or deliver detailed written and oral instructions.
Must be able to perform rudimentary mathematical calculations.
Key Competencies
Customer Focus: Ability to build strong customer relationships and deliver customer
centric solutions.
Optimizes Work Processes: Know the most effective and efficient processes to get
things done, with a focus on continuous improvement.
Collaborates: Builds partnerships and works collaboratively with others to meet shared
objectives.
Resourcefulness: Secures and deploys resources effectively and efficiently.
Manages Complexity: Makes sense of complex, high quality, and sometimes
contradictory information to effectively solve problems.
Ensures Accountability: Holds self and others accountable to meet commitments and
objectives.
Situational Adaptability: Adapts approach and demeanor in real time to match shifting
demands of different situations.
Communicates Effectively: Develops and delivers multi-mode communications that
convey a clear understanding of the unique needs of different audiences.
High School Diploma or equivalent required.
Previous manufacturing experience required. 503B experience preferred.
Experience with operation of equipment and/or tools required.

Lead Sterile Manufacturing Operator
 Previous cGMP experience required; LEAN manufacturing experience preferred.

  • Lead Sterile Manufacturing Operator

    3 months ago

    Los Angeles, United States Xseer Pharmaceuticals Full time

    Job DescriptionJob DescriptionPosition SummaryDuties And ResponsibilitiesThe Lead Sterile Manufacturing Operator (SMO) is responsible for overseeing, andexecuting where needed, all processes related to the manufacture of sterile product atXseer’s 503B facility. Manufacturing personnel must adhere to 21 CFR parts 210/211and USP / regulations, current Good...

  • Lead Pharmacist in Sterile Compounding

    3 hours ago

    Los Angeles, California, United States Xseer Pharmaceuticals Full time

    Job OverviewLead Pharmacist, Sterile CompoundingPosition Overview:The Lead Pharmacist in Sterile Compounding is tasked with managing the production processes for compounded sterile formulations, ensuring strict compliance with current Good Manufacturing Practices (cGMP), USP 797/800, and departmental Standard Operating Procedures (SOP). This role involves...

  • Lead Manager of Pharmaceutical Manufacturing

    7 minutes ago

    Los Angeles, California, United States Xseer Pharmaceuticals Full time

    Job OverviewLead Manager of Pharmaceutical Manufacturing - 503B Outsourcing Facility Position OverviewAs the Lead Manager of Manufacturing, you will play a pivotal role in Xseer Pharmaceuticals' mission to deliver innovative therapeutic solutions that enhance health and well-being. This essential position supervises the comprehensive manufacturing operations...

  • Senior Pharmacist, sterile compounding

    2 months ago

    Los Angeles, United States Xseer Pharmaceuticals Full time

    Job DescriptionJob DescriptionSenior Manager, Sterile Manufacturing/PharmacistPosition Summary:The Manager, Sterile Manufacturing is responsible for overseeing processes in the production ofcompounded sterile preparations, while strictly adhering to current Good ManufacturingPractices (cGMP), USP 797/800, and department Standard Operating Procedures (SOP)....

  • Sterile Processing Specialist II

    5 days ago

    Los Angeles, California, United States Kaiser Permanente Full time

    Kaiser Permanente is in search of a Sterile Processing Technician Level II to join our dedicated team.Position OverviewThe Sterile Processing Technician Level II plays a crucial role in ensuring the safety and efficiency of medical operations by managing the decontamination, cleaning, packaging, sterilization, storage, and distribution of medical and...

  • Sterile Processing Specialist II

    33 minutes ago

    Los Angeles, California, United States Kaiser Permanente Full time

    Kaiser Permanente is in search of a Sterile Processing Technician Level II to join our dedicated team in providing exceptional healthcare services.Position OverviewRole Summary:As a Sterile Processing Technician Level II, you will be responsible for the decontamination, cleaning, packaging, sterilization, storage, and distribution of medical and surgical...

  • Sterile Processing Technician II

    3 months ago

    Los Angeles, United States Kaiser Permanente Full time

    Description: 2K Sign on Bonus Eligible!Job Summary:Decontaminates, cleans, packages, sterilizes, stores and distributes medical/surgical, equipment and supplies in accordance with CDC, OSHA, EPA, AAMI, Title 22, APIC, SGNA, JC guidelines as required.Essential Responsibilities:Responsible for filling orders from requesting departments.Make equipment rounds...

  • Sterile Processing Technician II

    3 months ago

    Los Angeles, United States Kaiser Permanente Full time

    Job Summary: Decontaminates, cleans, packages, sterilizes, stores and distributes medical/surgical, equipment and supplies in accordance with CDC, OSHA, EPA, AAMI, Title 22, APIC, SGNA, JC guidelines as required. Essential Responsibilities: Responsible for filling orders from requesting departments. Make equipment rounds and return soiled equipment to SPD;...

  • Sterile Processing Technician II

    3 months ago

    Los Angeles, United States Keck Medicine of USC Full time

    Under general supervision of the Sterile Processing Supervisor or Sterile Processing Educator, the Sterile Processing Technician (SPT)II serve with basic knowledge of Sterile Processing techniques/skills and is responsible for decontaminating, operationally checking, assembling, sterilizing, and distributing reusable surgical/clinical instrumentation and...

  • Senior Manufacturing Manager

    3 weeks ago

    Los Angeles, United States Xseer Pharmaceuticals Full time $35 - $45

    Job DescriptionJob DescriptionSenior Manufacturing Manager - 503B Outsourcing Facility Position SummaryAs the Senior of Manufacturing, you will be at the heart of Xseer’s mission to produce innovative medications that help people live healthier and happier. This critical role oversees the entire manufacturing of our 503B Outsourcing Facility, ensuring...

  • Level II

    3 weeks ago

    Los Angeles, United States Kaiser Permanente Full time

    Kaiser Permanente is seeking a Sterile Processing Technician Level II for a job in Los Angeles, California.Job Description & RequirementsSpecialty: Sterile Processing TechnicianDiscipline: Allied Health ProfessionalDuration: Ongoing40 hours per weekShift: 8 hours, daysEmployment Type: Staff Job Summary: Decontaminates, cleans, packages, sterilizes, stores...

  • Level II

    3 weeks ago

    Los Angeles, United States Kaiser Permanente Full time

    Kaiser Permanente is seeking a Sterile Processing Technician Level II for a job in Woodland Hills, California.Job Description & RequirementsSpecialty: Sterile Processing TechnicianDiscipline: Allied Health ProfessionalDuration: Ongoing40 hours per weekShift: 8 hours, nightsEmployment Type: Staff2K Sign on Bonus Eligible!Job Summary:Decontaminates, cleans,...

  • head of manufacturing operations

    2 months ago

    Los Angeles, California, United States Rush & Company Full time

    This is a fast-growing materials innovation company focused on replacing materials like plastic and leather with plant-based alternatives. They innovate industry-defining chemistries in our Los Angeles lab and create low-carbon materials made from plants, supplying them to large companies within industries like automotive, fashion, furniture, and beyond....

  • Manufacturing Operations Leader

    5 days ago

    Los Angeles, California, United States Precision Castparts Corp Full time

    Job Overview:As a key figure in our organization, the Operations Manager will oversee a dedicated team responsible for the production and engineering of advanced fastening solutions. This role is pivotal in ensuring operational excellence and compliance with industry standards.Company Profile:Precision Castparts Corp is a global leader in manufacturing,...

  • Manufacturing Engineer, Downstream

    3 months ago

    Los Angeles, United States BioPhase Solutions Full time

    Job DescriptionJob DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Manufacturing Engineer, Downstream to work for a leading Greater Los Angeles area biopharmaceutical company.Salary: $120-140k+ depending on experienceResponsibilities:Work in...

  • Sterile Processing Technician I

    2 months ago

    Los Angeles, CA - Health Sciences Campus, United States Keck Medicine of USC Full time

    Under general supervision of the Sterile Processing Supervisor or Sterile Processing Educator, the Sterile Processing Technician (SPT) serve with basic knowledge of Sterile Processing techniques/skills and is responsible for decontaminating, operationally checking, assembling, sterilizing, and distributing reusable surgical/clinical instrumentation and...

  • Manufacturing Operations Manager

    5 days ago

    Los Angeles, California, United States Jobot Full time

    Dynamic company focused on plant-based sustainabilityThis Jobot Job is hosted by: Ray BahlAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $90,000 - $120,000 per yearAbout Us:We are a nationally recognized plant-based brand dedicated to sustainability. Our culture is built on collaboration and inclusivity. We...

  • Manufacturing Operations Leader

    5 days ago

    Los Angeles, California, United States Jobot Full time

    Dynamic company dedicated to plant-based sustainabilityThis Jobot Job is hosted by: Ray BahlAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $90,000 - $120,000 per yearAbout Us:We are a nationally recognized plant-based brand committed to sustainability. Our culture emphasizes collaboration and inclusivity....

  • Manufacturing Operations Planner

    6 days ago

    Los Angeles, California, United States Poise Staffing Partners, LLC Full time

    The Manufacturing Operations Planner position is a direct hire opportunity with a focus on optimizing production processes for a leading safety product manufacturer. In this role, you will play a pivotal part in overseeing and enhancing the planning for specific production lines. Your contributions will be essential in achieving efficient production...

  • Manufacturing Operations Supervisor

    5 days ago

    Los Angeles, California, United States Jobot Full time

    Dynamic and Innovative Company Focused on Sustainable PracticesThis position is hosted by: JobotSalary: $90,000 - $120,000 per yearAbout Us:We are a well-known brand in the plant-based sector, dedicated to sustainability and environmental responsibility. Our workplace fosters collaboration and inclusivity, making it a great environment for professionals...