Sterility Assurance Manager Job Listing at Kelly Services in Houston, TX (Job ID 9406631)

Description

Kelly Science & Clinical is currently seeking a Sterility Assurance Manager for one of our clients, a biopharma/biotech company in near Southwest Houston.
As a Sterility Assurance Manager you will be responsible for all areas related to environmental monitoring, aseptic processing and microbial control at our client's Houston GMP manufacturing facility. This individual will lead the effort in establishing and overseeing the environmental monitoring and aseptic processing programs to collect baseline data and set acceptance criteria for initial performance qualification. This role will also be responsible for maintaining the qualification status of operator training, aseptic filling processes and integrity testing.

Essential Responsibilities

• Establish environmental sampling maps for defined clean room areas
• Scheduling and participating in daily, weekly and monthly monitoring of the cleanroom environment
• Manage and training staff on operation of the MODA Environmental Monitoring (EM) data collection system
• Baseline sampling and initial performance qualification of the GMP manufacturing facility EM sampling of GMP Cleanroom suite during at-rest and in-operation activities
• Scheduling of Water system and clean steam sampling and testing
• Prepare and approve trending and technical reports
• Establishing alert and action limits based on statistical analysis of environmental data at rest and in operation
• Investigating and recommending corrective actions for environmental excursions
• Training and developing QC support staff in microbiological techniques and procedures
• Training and qualifying Manufacturing staff in aseptic techniques
• Maintaining aseptic process validation and operator qualification programs
• Support Manufacturing during aseptic processing simulation activities
• Support batch and raw material testing including growth promotion, bioburden, and endotoxin testing.
• Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
• Other activities as defined by the Director of Quality Control

Education/Skills Required

• BA or BS degree, Master's degree or higher in Microbiology, Biology or related science field
• A minimum of 5 years related experience in a GMP environment is required
• Previous supervisory experience preferred
• Experience using electronic systems (MODA EM) for data collection and technical report writing
• Working knowledge of current Good Manufacturing Practices (cGMP) related to Biologics manufacturing
• Good aseptic techniques
• Understanding of clean room HVAC operation
• In depth understanding of microbiology and statistics
• Knowledge of USP and EP endotoxin, bioburden and sterility requirements
• Knowledge of Microsoft Office products
• Time management skills required for organization of daily and weekly monitoring schedule
• Record keeping skills required to ensure accuracy and authenticity of data
• Organizational skills required for maintaining proper sample management

Job Details

• Direct hire
• M-F, day shift
• Salary DOE + Full benefits

#P1
 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

 Apply on company website