Senior Specialist, Quality Control – Microbiology

What a Sr. Specialist, QC Microbiology contributes to Cardinal Health:

• Reports to Manager, Quality Control (Microbiology).
• 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.

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, cleaning and aseptic processes 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.

Accountabilities

• Operates Equipment, Perform Analyst tests, interprets results and documents findings in accordance with SOPs and regulatory requirements (FDA, European Commission).
• 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.

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 processes 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 multi­task, self­starter and self­motivated.
• 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.

Necessary Knowledge, Skills, and Abilities

• Competent in the use of various computer programs such as Outlook, Microsoft Office. Experience with eQMS and material management systems an asset (Veeva, TrackWise, SAP etc.)
• 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.
   

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.

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.

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