QC Microbiologist and Environmental Monitoring Specialist

• First Shift, Mon-Fri
• $65,000 - $85,000 annual compensation
• Excellent Benefits Package
• Must be willing to follow FDA, CDC, EPA and OSHA guidelines.

Position Summary:

The QC Microbiology and Environment Monitoring specialist will become an integral part of Cell Ready Quality team. This role encompasses a spectrum of responsibilities, chiefly overseeing the GMP facility's environmental monitoring and contamination control programs. This includes the rigorous qualification of the facility, ensuring its sustained qualified status, conducting aseptic process simulations, establishing and enforcing disinfection procedures and practices, qualifying disinfectants, validating cleaning protocols, and exercising comprehensive oversight over the microbiological testing processes for raw materials and finished goods (Drug Product). Moreover, the QC Microbiology and Environment Monitoring specialist assumes accountability for spearheading the development, execution, and adherence to activities within the microbiology laboratory domain, all aimed at aligning with production targets, maintaining quality standards, and optimizing cost efficiency. This role will be central in all processes associated with environmental monitoring and integral with environmental investigations, excursion report writing, and general upkeep of the QC EM laboratory.

Responsibilities:

• Perform environmental and personnel monitoring within clean rooms ( ISO 5 – ISO 9 environments).
• Assist with maintenance of laboratory and media supplies.
• Perform and documents training on all laboratory general tasks and is capable of performing assigned test methods with minimal supervision.
• Serve as the primary subject matter expert in Microbiology, aseptic processing
• Oversee the Gowning Qualification and Training Program
• Support investigations for environmental excursions.
• Perform EM sampling for Aseptic Manufacturing Qualifications.
• Lead investigations to environmental excursions and assists with CAPAs
• Assist with data entry and annual EM trend reporting.
• Assist with laboratory equipment upkeep.
• Other duties as assigned.
• Assist in training of new hires and retraining of QC laboratory staff, as needed
• Completing any other relevant duties and responsibilities assigned by senior management.
• Ability to work on weekends or in rotating shifts if needed.

Qualifications:

• Minimum, Associate’s degree in biological sciences or related discipline, with 2 years of experience.
• Demonstrate knowledge in general laboratory skills and microbiological assays, and aseptic test methods.
• Knowledge of Good Manufacturing Processes (cGMP) and Good Laboratory Practices (GLP).
• A competent understanding and ability to create, review, approve a Change Control/SOP.
• Organizational, multitasking, problem-solving, math, statistical, interpersonal, written and oral communication skills. Detail-oriented and ability to prioritize work.
• Must be able to work within multi-functional teams.
• Ability to function well in a fast-paced environment.
• Strong manual dexterity
• Can easily work with little supervision
• Can lead a shift on occasion with confidence and competence
• High level of concentration and takes satisfaction in performing tasks with a high level of accuracy
• Good manual dexterity and mechanical aptitude
• Can easily read and interpret work instructions with a high level of accuracy
• Can easily fill out forms accurately and clearly.
• Identify mistakes and defects in workmanship
• Can easily anticipate problems before they occur
• Ability to communicate with all levels of staff clearly and do so professionally
• Can easily use tools and equipment
• Enjoy continually improving your skills
• Basic computer skills
• Must be able to read, write and understand English
• Ability to provide legal US work authorization documents required

Personal Attributes:

• Team player
• Do the right thing, even when no one is looking
• Great listener
• Accuracy is important
• Attention-to-detail
• Reliable
• Multitasker
• Critical thinking
• Strong team and interpersonal communication
• Quality focus
• Can work at a fast pace
• Even tempered
• Well organized
• Enjoys learning
• Conscientious
• Always conduct yourself with a high level of professionalism in our quest to save lives

Company Information

Cell Ready is a privately held contract development and manufacturing organization in Houston Texas, which makes cell and gene therapy drug products that provide incredible results for cancer patients.

With each drug product that we create, we provide cancer patients with a potential cure.

Due to the high market response to our groundbreaking approach to cell and gene therapy manufacturing, Cell Ready is expanding to a 70,000 sq. ft. facility and is increasing the size and competencies of its staff.

We are seeking a QC Microbiologist and Environmental Monitoring candidate that has a proven history of routinely making others around them better, taking on hard challenges and making them look easy, and consistently rising to any occasion.

Reasons to Apply:

• You will be an instrumental part of a team that will play a critical role in providing society with widespread access to Cell and Gene Therapies, which many believe is one of the most important advances in the history of cancer treatment.
• Cell Ready is a well-funded company with no debt.
• This combination of meaningful work and exceptional compensation is a rare opportunity.