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Senior Specialist, QC Microbiology

Company: Randstad USA
Location: Arcadia
Posted on: November 27, 2022

Job Description:

job summary:
Make a splash at this fast-paced and rapidly growing biotech start up! Here, you will contribute your talents in a purposeful way that impacts the lives of patients around the world. You will be supporting the development and manufacturing of cell and gene immunotherapies for the treatment of cancer and rare diseases, in a state of the art facility.

The Sr. Specialist, QC Micro has a unique opportunity to play a key role in building of the QC Microbiology laboratory from ground up for a Cell and Gene therapy biotech startup.

The Sr. Specialist, QC Micro will lead method transfer and validation studies, commission new equipment, author and edit Quality system procedures, lead continuous improvement initiatives, and represent QC on project teams for clinical and commercial products. Working with QA, manufacturing, and analytical development groups, the Sr. Specialist, QC Micro will be responsible for meeting QC timelines related to deliverables such as method transfer reports, test methods, change controls, and validation protocols and reports.

The Sr. Specialist, QC Micro will assist and support in the day-to-day operation of cGMP compliant Quality Control Microbiology laboratory to include performing and providing support for functional aspects of the facility such as environmental and utility monitoring (EM), microbiological testing, media fills, water testing, and other activities that will support execution of testing for cGMP samples for in-process, lot release and stability samples in-house. This role will be responsible for documentation that is compliant with all applicable procedures, standards, and cGMP regulations. The QC Microbiology Laboratory is a highly controlled environment, where significant attention must be paid to written procedures, safety, and cGMP compliance. Schedules and completing testing on time error free are of paramount importance. The lab is equipped with highly sensitive and expensive instruments which must be handled with care.

Hours: 8:30 AM - 5:00 PM

Apply now if you have:

  • Demonstrated in-depth knowledge of Microbiological methods across a wide range of technologies.
  • Proven scientific and technical ability to design and execute method development and validation experiments; analyze and present data; author and review protocol and reports, in support of regulatory submissions.
  • Demonstrated deep knowledge and experience of cGMP and the regulatory requirements for pharmaceuticals.
  • Must be a highly motivated and self-driven individual with the ability to work independently, and multi-task under aggressive timelines to support department and business objectives
  • Excellent analytical, technical writing, communication, and data management skills
  • Demonstrated expertise with a range of Microbiological test methods including Bioburden, Endotoxin, Environmental and Critical Utility Monitoring, Growth Promotion, Water analysis.
  • Knowledge of cGMP, ICH, pharmacopoeia, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required. Other regulatory agencies experiences preferred
  • Experience in the qualification of cell therapy equipment a plus
  • Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment
  • Working knowledge of Deviations, Change Controls, and CAPAs
  • Basic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standards
  • Strong understanding of Microbiology related to drug substance or drug product manufacturing.
  • Strong written and verbal communication skills in small and large group settings
  • Excellent interpersonal and teamwork skills with experience dealing with all levels within the company
  • Willingness to collaborate internally and with clients while following regulations
  • Strong multitasking ability in conjunction with proven organizational and record keeping skills
  • Ability to organize assigned tasks in a high paced environment and monitor tasks / assignments that may impact timely completion
  • Ability to effectively manage multiple tasks and activities simultaneously
  • Proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business -
    location: Arcadia, California
    job type: Permanent
    salary: $85,000 - 98,800 per year
    work hours: 9 to 5
    education: Bachelors
    -
    responsibilities:
    • Lead and manage the transfer and validation of test methods in support of drug substance release and stability testing.
    • Author test methods, validation protocols and reports, Quality system SOPs, and supporting documents.
    • Lead equipment onboarding and validation lifecycle, including operation and maintenance procedures of hardware and software systems.
    • Drive change controls, lead investigations, CAPAs, and continuous improvement initiatives to successful completion.
    • Represent QC Microbiology on project teams for clinical and commercial products with primary responsibility for validation of Drug Substance release assays.
    • Lead in performing validation of microbiological assays and provide training related to in-process and drug substance testing, equipment, environmental and utility monitoring to include Bioburden, Endotoxin, Growth Promotion testing, etc.
    • Assist and support to perform environmental and utility monitoring of the cell and gene therapy production facility according to written procedures while fully gowned including operational monitoring and personnel monitoring during aseptic processing, and aseptic filling. Assist and support to perform routine environmental monitoring, as needed to meet schedules.
    • Read environmental and utility monitoring plates by counting microbial colonies. Fill out appropriate reports and forms contemporaneously. Assist to perform microbial identification like gram stains, gene sequencing. Track all data and complete in a timely manner. Perform all activities in compliance with cGMP regulations.
    • Prepare and present quarterly and annual reports, trend investigations, statements of quality, and other applicable reports to management.
    • Lead onboarding and qualification of laboratory equipment and GMP software systems.
    • Generate and write SOPs and protocols related to test methods involving product lot release.
    • Draft technical documents including test methods, validation documents, and deviations.
    • Implement change controls, lead investigations, and complete CAPAs in support of GMP operations.
    • Assist in purchasing all necessary supplies, needed for QC Microbiology. Assist to receive supplies, log-in and store appropriately following written procedures. Assist to perform growth promotion analyses on all microbiological media lots received. Report results on appropriate forms.
    • Inspect and clean the laboratory and its equipment on a regular basis. Perform laboratory and equipment cleaning, preventative maintenance and calibration as described in written procedures. Follow written procedures for cleaning. Record all necessary information and maintain current, accurate, legible records of all work performed. Report problems to management in a timely manner and provide creative solutions to resolve them.
    • Ensure compliance to all quality requirements to meet audit standards and regulatory compliance.
    • Maintain lab equipment, reagents inventory, and documentation to ensure accurate, timely, and cost-effective analysis of materials and products.
    • Create training materials and train staff on methods and related SOPs.
    • Implement and qualify current and new pharmacopoeia methods to ensure compliance with cGMP's and other regulatory requirements.
    • Analyze and summarize data into reports and certificates of analysis with attention to details.
    • Lead risk assessments such as HAZOP's and FMEA's.
    • Propose corrective and preventive actions and improvements identified through investigations and audits and perform effectiveness checks of CAPA's.
    • Perform sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.
    • Collaborate with external clients, contractors, and vendors. -
      qualifications:
      • Bachelor's degree in Microbiology, Molecular and Cell biology, Biology or related field required. In lieu of this requirement, work experience may be considered
      • More than 7 years of work experience in the Pharmaceutical, Life Sciences industry with cGMP, GLP
      • A strong background in method development, qualification and validation is highly desired. A background in quality control testing related to Biopharmaceuticals is required.
      • Experience with problem solving methods such as DMAIC or other similar Root Cause Analysis Tools
      • Experience with electronic Laboratory Information Management Systems (LIMS)
      • Experience with relevant microbiology laboratory equipment and software.Working Conditions:

        • Laboratory environment
        • Must wear PPE due to safety requirements in designated lab areas
        • May be required to work in controlled or clean room environments -
          skills: Quality control, Cell Biology, SOP, Laboratory Information Management Systems (LIMS), GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System

          Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

          At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

          Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

          Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

          We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

          For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information. job summary: Make a splash at this fast-paced and rapidly growing biotech start up! This is a great opportunity for a curious learner to support the development and manufacturing of cell and gene immunotherapies for the treatment of cancer and rare diseases. Summary: The Senior Analyst, Lab Systems will play a key role in selection of vendors and systems, implementation, and maintenance of complex laboratory electronic systems. This role will lead in requ job summary: Make a splash at this fast-paced and rapidly growing biotech start up! Here, you will contribute your talents in a purposeful way that impacts the lives of patients around the world. You will be supporting the development and manufacturing of cell and gene immunotherapies for the treatment of cancer and rare diseases, in a state of the art facility. Position Summary: The Sr. Associate, Quality Control Analytic and Operations will be responsib job summary: Make a splash at this fast-paced and rapidly growing biotech start up! Here, you will contribute your talents in a purposeful way that impacts the lives of patients around the world. You will be supporting the development and manufacturing of cell and gene immunotherapies for the treatment of cancer and rare diseases, in a state of the art facility. The QC Microbiology Lab Specialist will assist in the method transfer and validation studies, We will keep you updated when we have similar job postings. select frequency I consent to the use of my information for the purpose of sending me job alerts.

Keywords: Randstad USA, Arcadia , Senior Specialist, QC Microbiology, Other , Arcadia, California

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