QC Microbiologist- First Shift - Randstad USA

job summary:

Seeking an Expert Scientist in Quality Control Microbiology with experience or specialty in endotoxin detection methods. This is an exciting and unique role where the applicant will have the opportunity to implement novel technology into biological and pharmaceutical products and processes.

 
location: Rockville, Maryland
job type: Contract
salary: $40.00 - 43.29 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:

Drive implementation of new and rapid microbiology technologies that ensure data integrity, meet company quality standards, and support regulatory submissions and delivery of quality medicines for patients.

- Design and execute method development and GMP validation for recombinant factor C endotoxin testing.

- Contribute to method development and method qualification.

- Perform laboratory operations to support and implementation of compliant, state of art methodology and instrumentation.

- Provide scientific understanding and analytical support for development of new test method, validation, and specifications.

- Support for scientific report writing and document revision.

- Provide analytical troubleshooting support for investigations which require non routine/specialized service.

- Support microbiology technology validation and implementation for testing pharmaceutical products and manufacturing environment.

- Provide validation and testing data for these new methods and technologies for internal advocacy and external regulatory submission.

- Facilitate method transfer, validation, and implementation of new microbiology technologies at secondary commercial sites.

- Work to GMP standards as appropriate.

- Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.

 
qualifications:

Minimum Qualifications:

- BSc in Biological Sciences or related area; Microbiology, Biochemistry or a related subject.

- 3 years or more experience in working in research and/or analytical development and/or quality control functions.

- Demonstrated experience and good working knowledge of method development, method validation/qualification.

- Experience with GMP laboratory operations.

- Strong team working skills, able to perform collaborative work across interdisciplinary groups.

- Strong desire to learn/scientific curiosity, with cross functional learning agility.

- Good organizational skills, ability to multitask and adapt to fast changing priorities and deadlines.

- Excellent verbal and written communication (English)

- Self-motivation.

Preferred Qualifications

- An understanding of the theoretical and practical aspects of Pharmaceutical Microbiology (knowledge of rapid/alternative methodologies an advantage).

- Demonstrated hands-on and/or practical experience in endotoxin detection methods of pharmaceutical products and/or water.

- Capacity to think innovatively and flexibly for new microbiology methodology implementation, comfortable with complexity.

- Experience in microbiology method and equipment development and/or validation.

- Knowledge of biological and pharmaceutical product manufacturing and microbial control.

- Experience with FDA regulations.

 
skills: FDA, MS-WORD, MS-EXCEL, MS-Powerpoint, GLP (Good Laboratory Practice), Microbiology, GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Applications accepted on ongoing basis until filled.