Position Description: Quality Control Microbiologist I/II

Job Title | QC Microbiologist I/II
Location | La Jolla, CA
Department | QC Microbiology

Summary

The major purpose of this position is the performance and reporting of microbiological testing for product release. In addition, this person participates in the performance of test failure and related investigations and the performance, reporting, and development of assays as required. The position ensures that the company goals for timely product testing are accomplished by being directly involved in the production of test results for product release and investigations.

Essential Duties and Responsibilities

The duties and responsibilities of this position include the following, although other duties may be assigned.

The primary duty of this position is the performance and reporting of microbiological testing for product release. This person is also involved in executing testing protocols that support the development of new assays or special projects. Other responsibilities include performing test failure investigations, compiling data, evaluating the product by statistical methods, writing SOPs, writing protocols and reports, recording daily monitoring data for laboratory equipment and assisting in raw material inspections by performing microbiological testing as required in order to comply with inspection requirements.

% of Time	Job Task
50	Performance and reporting of safety testing for product release, and other related testing.
10	Compilation and entry of environmental monitoring data, Reviewing of EM Data.
10	Recording and reviewing of test reports.
10	Assisting in raw material inspections by performing microbiological testing as required.
10	Performing the required testing for protocols.
10	Revising of Standard Operating Procedure (SOP) as required.

Supervisory Responsibilities

Position has no supervisory responsibilities.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Handling biohazardous materials and chemicals
• Basic laboratory safety procedures
• A detailed knowledge of cGMP, GLP and FDA regulations and compendial requirements for drugs, biologic and biotechnological products
• Proficiency with the computer software necessary to perform data handling tasks as well as accessing e-mail and filing out timesheet reports. (Microsoft Excel, Word, Outlook and Access)
• Good communication skills both written and verbal
• Familiarity with handling OOS, retest and assay validation requirements
• Familiarity with statistical analysis techniques to trend and analyze test data
• Some experience with assay development, assay validation and reagent qualification
• Strong background in aseptic techniques, Environmental Monitoring (EM), Bioburden, Endotoxin, Sterility, and Bacteriostatis/Fungistasis testing.

Education and Experience

BS degree in Microbiology, Biology or equivalent QC related field and 3 years experience in a GMP or similarly regulated environment such as a pharmaceutical drug manufacturing, biologics or biotechnology company.

Language Skills

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write reports, correspondence, and procedure manuals.

Mathematical Skills

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Physical Demands

The physical demands described here 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.

Requirements include following gowning procedures: clean room gowning, lab coats, gloves and sleeves.

The working environment includes working with chemicals such as strong acids and bases and will also involve exposure to human tissue products.

All qualified resumes should be submitted directly to careers@abh.com

We are an Equal Opportunity Employer.