Microbiologist – Pharmaceutical - QC from Management Recruiters of Edison

Our client – a growing company with multiple plants in the US, needs a Microbiologist in their Quality group at their plant expanding to manufacture pharmaceutical products. Excellent salary + Relocation Assistance + Full Benefit Package (13 days PTO + 401K)

Job Posting # 2650

Job Title: Microbiologist – Pharmaceutical - QC              Location:  Lawrence, KS                            

Compensation: Salary of $60K - $85K per year  

 
Relocation:  YES - Client offers relo assistance for reasonable expenses

Benefits:  Full package for medical, dental insurance, 401K + 13 days - PTO, etc.

 Our client is a privately held company with manufacturing sites in CA + KS with around 300 people

Group Info:  Be part of the medical device and pharmaceutical contract manufacturing site with around 120+ employees and expected to grow to 150 people soon due to major expansion in Pharma manufacturing.

The new operation expansion is for Pharma Fill Finish Seal – FFS of Sterile Aseptic liquids.

This Quality group has around 25 people from Quality Control, Quality Assurance, Compliance. This person will be responsible for all the Environmental Testing and report to the QC Manager with a group of 10 people.

Job Summary:

• Microbiologist will perform day-to-day activities relating to the microbiological, environmental, and quality processes and practices at the site applicable to the company’s regulatory and statutory requirements.
• This position provides testing and technical support for environmental monitoring, sterility, endotoxin, particulate monitoring, and other methods as assigned.
• The incumbent will support pharmaceutical and medical device manufacturing operations under the direction of the Quality Control (QC) Manager.
• The incumbent is responsible for following company policies, cGMPs, and all Standard Operating Procedures as mandated for this position.

Note 1: Extensive years of related Quality experience will be considered in place of a BS degree

Job Description: 

• Provide technical knowledge for sterilization processes in conjunction with support in the resolution of plant challenges, method development, and project work.
• Individuals can be able to perform EMs, Bioburden tests, sterility tests, and other tests as assigned without supervision.
• Individuals must know about performing pH, conductivity, and media preparation as well.
• Conduct testing per schedules for the timely release of products and materials in alignment with the business goals and priorities.
• Provide oversight and technical knowledge to ensure the pharmaceutical site cleaning and disinfection program is adequate to ensure control of the cleanroom environment to applicable company, regulatory, and statutory requirements.
• Support activities as assigned by QC Management to facilitate testing, qualification, system improvements, and compliance [Change Controls, CAPA, Out of Specification (OOS), Validation documents, Laboratory Investigations, and Standard Operating Procedures].
• Conduct sampling and testing to ensure proper microbiological monitoring of plant utility systems, including routine trend analysis.
• Provide oversight and technical knowledge in developing solutions to environmental, particulate, microbial, and sterilization challenges for the site and the QC Lab.
• Maintains a safe and healthy work environment by following standards and procedures and complying with legal regulations.
• Operate in compliance of cGMP, 21CFR and USP regulatory requirements.

Candidate Must Have:

• Bachelors of Science in Microbiology or relate science field.
• 2 years of QA/QC experience
• 1 year of experience in Medical Device or BioPharma– FDA regulated IndustryFlexibility and ability to manage multiple and competing priorities.
• Ability to multi-task with strong sense of urgency; ability to meet deadlines.
• Self-motivated, dependable, well organized.
• Able to communicate effectively and efficiently, both orally and in writing.
• Must hold excellent problem-solving skills.
• Excellent attention to detail and capable of performing dependable, accurate work.

Candidate Nice to Have:

• Knowledge of Sterile Aseptic Filling Operations
• Startup or Small company experience working in a dynamic and hands-on role.
• Contract Manufacturing experience working closely with customers and clients

Keywords: BioPharma, Pharma, Quality, QC, QA, FDA, Microbiology Bioburden sampling, environmental monitoring, CMO, Sterile Aseptic, CDMO, Manufacturing, Plant