Principal Specialist, QC Microbiology (Pharmaceutical)

Cardinal Health•Indianapolis, IN

56d

About The Position

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.

Requirements

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.
Bachelor's 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.

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, cGMP's and general quality.
Assists with the general upkeep of the microbiology laboratories and equipment.
Assists in the training efforts of the laboratory personnel.