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Principal Specialist, QC Microbiology (Pharmaceutical)
Principal Specialist, QC Microbiology (Pharmaceutical)Cardinal Health • Indianapolis, Indiana, USA
Principal Specialist, QC Microbiology (Pharmaceutical)

Principal Specialist, QC Microbiology (Pharmaceutical)

Cardinal Health • Indianapolis, Indiana, USA
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  • [job_card.full_time]
[job_card.job_description]

What a Principle Specialist Quality Control (Microbiology) contributes to Cardinal Health

  • Reports to Manager Quality Control (Microbiology).
  • Serves as the site technical expert for microbiological testing (environmental monitoring sterility testing bioburden testing equipment calibrations and other microbiological testing as required).
  • Provides guidance and leadership to QC and Operations personnel to ensure environmental monitoring and aseptic operations are executed per established policies and procedures.
  • Review and authoring of test methods standard operating procedures protocols deviation reports investigation reports and trending reports.
  • Adheres to established policies and procedures.

What Quality Control contributes to Cardinal Health

  • Demonstrates detail-oriented attention in all facets of responsibilities.
  • Performs analytical evaluation and testing of products or processes.
  • Demonstrates knowledge of test methods product usage and applicable regulations and standards.
  • Adheres to established policies and procedures.
  • Establishes test methodology.
  • Provides technical guidance and training to others on SOPs and quality guidelines.

    • What is expected of you and others at this level

  • Applies comprehensive knowledge and thorough understanding of concepts principles and technical capabilities to perform varied tasks and projects.
  • Works on complex projects of large scope.
  • Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives.
  • Completes work independently; receives general guidance on new projects.
  • Act as a mentor to less experienced colleagues.
  • Exhibit professional conduct and respect for others.

    • Responsibilities

  • Operates Analytical Equipment Perform Analyst tests interprets results and documents findings in accordance with SOPs and regulatory requirements.
  • Assists in and / or conduct laboratory investigations of discrepancies to resolve problems and works with Management to ensure corrective or preventive actions are implemented in a timely manner.
  • Responsible for the development and validation of new analytical methods as needed in alignment with ICH requirements.
  • Represents the department internally and externally in matters relating to the Microbiology Laboratory cGMPs and general quality.
  • Assists with the general upkeep of the microbiology laboratories and equipment.
  • Assists in the training efforts of the laboratory personnel.

    • Work Environment

  • The primary work environment consists of a professional office environment within a radiopharmaceutical manufacturing facility as well as the laboratory setting.
  • The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies and that are enforced by the corporate internal quality and regulatory groups.
  • Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

    • Qualifications

  • Bachelors degree in Microbiology / Biology or related field preferred or equivalent industry experience.
  • 5 years in the pharmaceutical or biotechnology industry with emphasis in one of the following areas preferred : QC microbiology environmental monitoring critical systems monitoring quality control aseptic manufacturing.
  • Experience in authoring a variety of forms of documentation such as SOPs Change Controls CAPAs Deviations and Laboratory Investigations is desirable.
  • Must be detail oriented organized able to multitask a selfstarter and selfmotivated.
  • Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
  • Demonstrated success in collaborating with people and working on a team.
  • Strong communications skills.
  • Competent in the use of various computer programs such as Outlook Word Excel and PowerPoint.
  • Excellent communication documentation and organization skills.
  • General knowledge of industry regulations pertaining to cGMP.
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing this job the employee is frequently required to stand; walk; use hands to finger handle or feel; and reach with hands and arms; balance; stoop kneel crouch or crawl; talk or hear; and taste or smell. The employee must occasionally lift or move up to 25lbs. Specific vision abilities required by the job include close vision distance vision peripheral vision depth perception and the ability to adjust focus.

    • Anticipated salary range : $80900-$115500.

    Bonus eligible : No

    Benefits : Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

  • Medical dental and vision coverage
  • Paid time off plan
  • Health savings account (HSA)
  • 401k savings plan
  • Access to wages before pay day with myFlexPay
  • Flexible spending accounts (FSAs)
  • Short- and long-term disability coverage
  • Work-Life resources
  • Paid parental leave
  • Healthy lifestyle program

    • Application window anticipated to close : 2 / 2 / 2025

  • if interested in opportunity please submit application as soon as possible.

    • The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including but not limited to a candidates geographical location relevant education experience and skills and an evaluation of internal pay equity.

    Candidates who are back-to-work people with disabilities without a college degree and Veterans are encouraged to apply.

    Cardinal Health supports an inclusive workplace that values diversity of thought experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race religion color national origin ancestry age physical or mental disability sex sexual orientation gender identity / expression pregnancy veteran status marital status creed status with regard to public assistance genetic status or any other status protected by federal state or local law.

    To read and review this privacy notice click here

    Required Experience :

    Staff IC

    Key Skills

    Academics,Ale,Asset Management,Legal Operations,Art And Craft,Database Administration

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

    Monthly Salary Salary : 80900 - 115500

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