Quality Control Microbiologist

Job Details

Grove City OH - Grove City, OH

Full Time

Bachelor's Degree

None

Standard Business Hours

QA - Quality Control

Description

Tosoh Bioscience LLC is a major supplier of chromatography products to the pharmaceutical, biotechnology, and chemical industries. Our product line includes:TSKgel, TOYOPEARL, and Ca++Pure-HA bulk media, TSKgel U/HPLC columns, process development products, dedicated systems for GPC analysis, and the LenS3 MALS detector. We have optimal solutions for biological research, drug discovery, medicinal chemistry, agriculture, manufacturing, or other industrial applications.

Summary

The Quality Control Microbiologist is responsible for supporting operations of the Tosoh Bioscience LLC quality control laboratories located in Grove City, OH. This position works with the Quality Control and Production teams to ensure compliance with Tosoh Bioscience’s quality standards for products used in cGMP manufacturing. The Microbiologist works in collaboration with the Senior Microbiologist as an expert in the assigned area. Technical and/or detailed instruction is provided only upon request when necessitated by a procedural change and/or special project.

Reporting Relationships

Reports to the Quality Control Manager. This position has no supervisory responsibilities.

Major Duties and Responsibilities

The Quality Control Microbiologist will perform microbiological examination of finished product within structured regulatory and quality frameworks (e.g. ISO 9001).

Perform Environmental Monitoring of manufacturing environment and critical Utilities (water system).

Monitoring of surface, air, and nonviable air quality of ISO 7 and 8 cleanrooms.

Review and trend environmental monitoring data and publish quarterly and annual trend reports.

Perform bioburden and endotoxin testing.

Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility.

Participate in microbial method validation and special projects related to improvement and validation projects.

Perform a variety of microbiologic assays such as culture purity, growth promotion, culture viability, and other tests needed by the Quality Control group

Identification of microbial isolates by selective plating and PCR (polymerase chain reaction).

Perform general laboratory duties, in house media preparation, and housekeeping.

Documentation of data/reports per local procedures and quality requirements.

Operate basic software like Microsoft Office and Quality Management Systems.

Work independently and with the team effectively to achieve individual, team and organizational goals.

Documentation of laboratory work following Good Documentation Practices.

Following established safety guidelines to safely work with materials that have biohazard potential.

Professional interactions with customers.

Maintain regular and reliable attendance.

Uphold and adhere to the Tosoh Bioscience culture and guiding principles.

Education

Bachelor of Science degree in Microbiology, molecular biology, or related field.

Skills and Qualifications

1-3 years of lab experience in a cGMP or ISO 9001 environment required with a minimum of 1 year working in a microbiology laboratory, preferably from work in the biopharmaceutical industry or having CMO or CRO experience.

Knowledge of Aseptic Techniques and working in clean room environments.

Ability to understand, follow, and draft written procedures.

Proven ability to conduct experiments according to standard operating procedures.

Previous participation in regulatory audits preferred.

Extensive knowledge of GMP regulations in cGMP manufacturing environment required.

Good oral and written communication skills.

Ability to interact effectively with management and prioritize multiple projects.

Ability to work in a team environment.

Occasional domestic travel may be required.

Physical Requirements

The physical demands of this job are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Sufficiently medically fit to work in the laboratory to perform assigned duties including the ability to wear personal protection equipment (PPE), lift up to 50 pounds, and work in the proximity of hazardous/infectious materials. Occasional domestic travel may be required.

Tosoh Bioscience LLC is an Equal Opportunity Employer M/F/Disabled/Veterans