Quality Control Microbiologist

Cardinal Health, Inc.; Indianapolis (IN); On-site; USD 67,000 - 97,000; Full time

Job summary

A leading company is seeking a Senior Specialist in Quality Control (Microbiology) to ensure compliance with standards and oversee microbiological testing. This role involves training, documentation, and operational support within the microbiology laboratory, contributing to high-quality product assurance in the pharmaceutical sector. Candidates should have relevant industry experience and a bachelor's degree in a scientific field.

Benefits

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before payday with myFlexPay

Flexible spending accounts (FSAs)

Short- and long-term disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Qualifications

• 2-4+ years in pharmaceuticals or biotechnology focusing on QC Microbiology.
• Experience in authoring SOPs, Change Controls, CAPAs, and Deviations.
• Must be proficient in Microsoft Office and possess strong technical writing skills.

Responsibilities

• Serves as a Microbiology technical expert for testing and documentation.
• Responsible for effective microbiological testing in compliance with regulations.
• Operates lab equipment, performs analyst tests, and documents findings.

Skills

Detail oriented

Organized

Team collaboration

Technical writing

Strong communication

Education

Bachelor’s degree in Microbiology/Biology or related field

Tools

Microsoft Office

Job description

What Quality Control contributes to Cardinal Health

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Control is responsible for the analysis or inspection of materials, components, products or processes for compliance with specifications and standards.

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

Quality Control is responsible for the analysis and inspection of products or processes for compliance with specifications and standards.

• Serves as a Microbiology technical expert for testing, documentation, and general laboratory operations.

• Responsible for the efficient and effective microbiological testing in conformance with regulations and standards.

• Provides guidance to personnel to ensure environmental monitoring, cleaning and aseptic operations are executed per established policies and procedures.

• Review and authoring of test methods, standard operating procedures, master batch records, media fills, deviation and investigation reports.

• Adheres to established policies and procedures.

Responsibilities

• Operates equipment, perform analyst tests, interprets results and documents finding in accordance with SOPs and regulatory requirements (FDA, European Commissions, etc.).

• Assists in and/or conduct laboratory investigations of discrepancies to resolve issues and works with Management to ensure corrective or preventive actions are implemented in a timely manner.

• Represents the department internally 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.

• May perform other job duties as assigned.

• 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. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color 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, the materials warehouse 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 he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

Qualifications

• Bachelor’s degree in Microbiology/Biology or related field preferred, or equivalent industry experience.

• 2 – 4+ 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 Processing and 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 multi-task, self-starter and self-motivated.

• Must be proficient in Microsoft Office (Word, Excel, PowerPoint) and possess strong technical writing skills.

• Demonstrated success in collaborating with people and working on a team.

• Strong communications skills.

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 action to resolve

• Applies judgment within defined parameters

• Receives general guidance and may receive more detailed instruction on new projects

• Work reviewed for sound reasoning and accuracy

Anticipated salary range:$67,500- $96,400

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 programs

Application window anticipated to close:8/19/2025 *if interested in opportunity, please submit application as soon as possible.

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.