Cardinal Health QC Microbiologist in Indianapolis, Indiana
What a QC Microbiologist (Sr. Specialist, Quality Control -Microbiology) contributes to Cardinal Health
- Reports to Manager, Quality Control.
- Responsible for the efficient and effective performance of microbiological testing in conformance with regulations and standards. Functions include environmental monitoring, purified water testing, sterility testing, Bioburden testing and investigational testing.
What Quality Control contributes to Cardinal Health
Quality control is responsible for the analysis or inspection of products or processes for compliance with specifications and standards.
- Demonstrates detailed oriented attention in all facets of responsibilities.
- Performs analytical evaluation or test of products or processes.
- Demonstrates knowledge of testing 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.
- Performs various microbiological testing procedures for environmental monitoring, purified water sampling, sterility testing, bioburden testing, endotoxin testing and investigational writing.
- Works with QC Microbiology management to ensure timely performance of microbiological testing procedures.
- Informs QC Microbiology management in a timely manner of any out of specifications (OOS-Out of Specification) or exceedance of Alert or Actions Levels.
- Performs thorough investigations following required procedures.
- Performs validation protocols and summary reports for equipment and methods.
- Updates and revises standard operating procedures and analytical methods.
- Handles analysis of raw materials, drug substance, in-process and drug product testing.
- Analyzes, interprets, reviews, and reports data in a timely manner.
- Performs other job duties as assigned.
- Bachelor’s degree in related field, or equivalent work experience preferred (microbiology, biology, or related science discipline)
- 2+ years experience in related field, preferred
- Competent in the use of various computer programs of MS Access and Excel preferred
- Excellent communication, documentation, and organization skills
- General knowledge of FDA regulations pertaining to CGMP preferred
Physical/ Mental Requirements
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 the duties of this job the employee is regularly required to talk or hear. 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 25 pounds. Specific vision abilities required by the job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus
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 welt-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 he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate
What is expected of you and others at this level
- Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
- Works on projects of moderate scope and complexity
- Identifies possible solutions to a variety of technical problems and takes actions to resolve
- Applies judgment within defined parameters
- Receives general guidance may receive more detailed instruction on new projects
- Works reviewed for sound reasoning and accuracy
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 (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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