Sterility Assurance Manager (contract) Job Listing at Kelly Services in Houston, TX (Job ID 10103396)

Description

Job Title: Sterility Assurance Manager (contract)
Location: Houston, TX
Rate: $55-65/hour
Duration: 6 months
Work Schedule: Full time | Day shift
 
Company Background
Our clients mission is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. They develop novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders.
 
As an employee, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.
 
Position Overview
Reporting to the Director, Quality Control, the Sterility Assurance Manager will be responsible for all areas related to environmental monitoring, aseptic processing and microbial control at our clients Houston GMP manufacturing facility. This individual will lead the effort in establishing and overseeing the environmental monitoring and aseptic processing programs including working with Manufacturing and Validation personnel 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. The Sterility Assurance Manager will be responsible for monitoring the state of control of the clean room environment, processes and personnel to ensure uninterrupted supply of clinical products.
 
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.
• Other activities as defined by the Director of Quality Control.

 
Essential Details: 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.
 
Scope: Works on problems of moderate scope. Exercises judgment within defined procedures and policies in selecting methods and techniques in obtaining solutions and in determining appropriate action. Interprets results in comparison to established specifications.
 
Leadership Responsibility: This individual may manage one or more QC analyst level positions. This will include team member training, scheduling, supervision and performance review.
 
Minimum Requirements:

• BA/BS, Master's degree or higher in Microbiology, Biology or related science field.
• 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.
• Understanding of clean room HVAC operation and aseptic techniques.
• 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.
• Good aseptic technique.

 
Working Conditions
A majority of the work is done in a laboratory environment. Work may involve high energy hazards, such as high-pressure gases, flammable materials, cryogenic operations, and chemical hazards such as strong acids and bases. In some areas, gowning (e.g., coveralls, face mask, shoe covers, hair and beard nets etc.) will be required.
 

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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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