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    Quality Systems Lead Scientist - Richmond, United States - California Department of Public Health

    California Department of Public Health
    California Department of Public Health Richmond, United States

    3 weeks ago

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    Description
    Job Description and Duties


    Candidates in one of these classifications, where a Master's Degree is required to meet the minimum qualifications, shall receive an educational pay differential equivalent to 2% of their monthly base pay.

    Those where a Doctoral Degree is required to meet the minimum qualifications, shall receive an educational pay differential equivalent to 3% of their monthly base pay.

    Individuals with both a Master's and Doctoral Degree will be given the best benefit in relation to salary shall only be eligible for only one amount.

    This position supports the California Department of Public Health's (CDPH) mission and strategic plan by ensuring that scientists and microbiologists adhere to regulatory guidance and perform high quality laboratory testing.

    The Research Scientist IV will be responsible for providing leadership and guidance to ensure quality policies, process, and procedures are established across multiple laboratory programs in the Center for Laboratory Sciences (CLS).

    Conceives, plans, and conducts scientific research work with the goal of enhancing and expanding the capacity and capability of CLS testing procedures through quality, safety, and effective methods.


    Develops Quality Management Systems in compliance with regulatory standards, reviews records and SOPs for effectiveness and efficiency, coordinates with SOP authors, records comments, and complaints, initiates corrective action process, and provides guidance on conducting root cause analyses to implement regulatory changes/improvements, and reports findings and resolutions to laboratory systems to meet quality standards documentation.

    Maintain records, coordinate assessments, oversee document control. Establish and maintain a strong leadership role with recruitment and retention strategies. Represents department at external laboratory quality meetings and participates in legislative and regulatory package work.
    Minimum Requirements

    You will find the Minimum Requirements in the Class Specification.
    RESEARCH SCIENTIST IV (MICROBIOLOGICAL SCIENCES)
    RESEARCH SCIENTIST IV (CHEMICAL SCIENCES)
    Special Requirements


    In order to be considered for this position, you must submit a copy of your college transcripts official or un-official and/or Degree for education verification.

    For experience/education to qualify during the application screening process, and to ensure that minimum qualifications can be determined, applicants should include all employment history on the Employment Application (STD 678) and/or Resume, including detailed job descriptions, hours worked per week, and start/end dates (MM/DD/YYYY).

    Application packages without this information will experience delayed processing times and your eligibility for this position may be impacted.
    A completed State application (STD. 678) and any other relevant documents (e.g. unofficial transcript, copy of degree, resume, etc.) should be submitted electronically via your CalCareers Account. Please reference Job Control # and indicate the basis of your eligibility in the Examination(s) or Job Title(s) section. SROA and surplus candidates should submit a copy of their letter with their application. Please remove any confidential information (i.e. social security number, date of birth) from your documents prior to submission.

    Complete Application Packages (including your Examination/Employment Application (STD 678) and applicable or required documents) must be submitted to apply for this Job Posting.

    Application Packages may be submitted electronically through your CalCareers Account at Submitting an electronic application through your CalCareers account is strongly recommended since electronic applications will be received/processed faster than other methods of filing.

    Please submit only one application.

    If you are unable to submit your application electronically through your CalCareers account, please email for assistance and a CDPH Human Resources Division staff member will contact you to assist with the online application process or, a hard copy application package may be submitted through an alternative method as explained in the How to Apply section below.

    When submitting your application in hard copy, a completed copy of the Application Package listing must be included.
    Required Application Package Documents
    The following items are required to be submitted with your application.

    Applicants who do not submit the required items timely may not be considered for this job:


    Current version of the State Examination/Employment Application STD Form 678 (when not applying electronically), or the Electronic State Employment Application through your Applicant Account at All Experience and Education relating to the Minimum Qualifications listed on the Classification Specification should be included to demonstrate how you meet the Minimum Qualifications for the position.

    Resume is required and must be included.
    Statement of Qualifications -

    Please see Statement of Qualifications instructions below at end of posting.

    Any applications received that do not provide a written response to the SOQ will not be scored/reviewed.


    Applicants requiring reasonable accommodations for the hiring interview process must request the necessary accommodations if scheduled for a hiring interview.

    The request should be made at the time of contact to schedule the interview. Questions regarding reasonable accommodations may be directed to the EEO contact listed on this job posting.

    Statement of Qualifications (SOQ) Instructions


    Statement of Qualifications question:


    Based on the duty statement for this position, describe how your employment and educational experience qualifies you for this position.



    NOTE:
    When responding to the question, applicants must follow these guidelines:


    • Response must be typewritten or generated by word processing on 8-1/2 x 11 paper, using no smaller than an 11-point font.
    • Response should be no longer than a total of two pages, single spaced, with 1-inch margins.
    • Identify each page with your full name and position number.
    • Ensure your response is complete, specific, clear, and concise.
    PLEASE

    NOTE:

    Resumes, letters, Supplemental Questionnaire, transcripts, degrees, your state application, cover letters and other materials will not take the place of the Statement of Qualifications.

    Simply copying and pasting your resume will also not be accepted. Applications received without an SOQ may be rejected.
    Desirable Qualifications

    In addition to evaluating each candidate's relative ability, as demonstrated by quality and breadth of experience, the following factors will provide the basis for competitively evaluating each candidate:
    Educational Background

    Advanced Degree:
    A Ph.
    D. or equivalent in a relevant scientific field (e.g., biology, microbiology, chemistry, biomedical sciences, or related disciplines). 2.


    Specialized Training:

    Additional certifications or training in quality management systems for laboratory accreditation highly desired (e.g., CLIA and ISO 9001, ISO 17025, Good Laboratory Practice (GLP), or Six Sigma).

    Professional Experience

    Extensive Research Experience:
    Several years of hands-on laboratory research experience, with a proven track record of scientific publications and contributions to the field


    2 Quality Management Experience:
    Demonstrated experience in developing, implementing, and managing quality management systems within laboratory environments


    3 Regulatory Compliance:
    Experience with regulatory standards and compliance, including FDA, EPA, OSHA, and other relevant agencies.

    Skills and Competencies

    Scientific Expertise:
    In-depth knowledge of scientific principles, laboratory techniques, and testing procedures


    2 Quality Assurance Skills:
    Proficiency in quality assurance methodologies, process improvement, and quality control


    3 Regulatory Knowledge:
    Strong understanding of regulatory requirements and standards applicable to laboratory operations


    4 Project Management:
    Excellent project management skills to oversee multiple laboratory programs and initiatives


    5 Analytical Skills:
    Strong analytical and problem-solving skills to conduct root cause analysis and implement corrective actions


    6 Communication Skills:
    Effective verbal and written communication skills to coordinate with stakeholders, authors, and regulatory bodies, and to report findings and resolutions


    7 Detail-Oriented:
    Attention to detail for reviewing records, Standard Operating Procedures (SOPs), and ensuring compliance and effectiveness


    8 Technical Writing:
    Proficiency in drafting and reviewing technical documents, including SOPs, quality manuals, and regulatory reports.

    Personal Attributes

    Leadership:
    Ability to lead and inspire a team, fostering a culture of quality and continuous improvement and collaboration across laboratory programs


    2 Collaborative Mindset:
    Strong interpersonal skills to work effectively with cross-functional teams and external partners


    3 Adaptability:
    Flexibility to adapt to changing regulations, technologies, and scientific advancements


    4 Ethical Conduct:
    Commitment to maintaining high ethical standards and integrity in all research and quality assurance activities.

    Additional Considerations

    Professional Affiliations:
    Membership in professional organizations (e.g., American Society for Quality (ASQ), Association for the Advancement of Medical Instrumentation (AAMI)). 2.


    Continuous Learning:
    Commitment to ongoing professional development and staying current with industry trends and regulatory changes.
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