Analyst II, QC Microbiology

Location
Baltimore (Bayview), MD, US
Posted
Sep 05, 2020
Ref
673206700
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Emergent BioSolutions is committed to assisting employees achieve their professional goals. Internal job postings are one of the tools available to employees at Emergent BioSolutions to assist in their career management. This enables current employees who have remained in their current position for a minimum of one year to apply for an open position.

I. JOB SUMMARY

The QC Analyst II, Microbiologist position supports the Quality Control group at Emergent BioSolutions Bayview Campus to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the EMOB Microbiology, Environmental Monitoring, and Clean Utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives. The individual routinely conducts monitoring, testing, SOP generation and revision, investigation and change control coordination, and implementation of new microbiological programs such as microbial identification. This position support the second shift operations at the Bayview manufacturing site.

II. ESSENTIAL FUNCTIONS
General
• Writes, revises, and reviews laboratory procedures
• Coordinates and processes departmental change controls
• Supports daily collection of utility and environmental samples, including water and steam sample collection
• Laboratory sample receipt and tracking
• Packaging and sending samples to contract laboratories
• Compendial testing such as MLT, growth promotion, endotoxin, TOC and conductivity
• Equipment/instrument standardization and calibration, as required for testing per SOP's
• Completion of GMP worksheets
• Coordinates and performs laboratory investigations
• Data review and trending to ensure integrity and adherence to standard operating procedures and cGMPs
• Data entry into laboratory data system
• Maintain inventory of laboratory supplies
• Daily laboratory upkeep and maintenance
• Performs activities supporting validation activities
• Support validation of support equipment such as autoclaves
• Provide support for swab recovery studies and cleaning validation
• This position performs routine microbial analysis of product samples
• Performs required data analysis, compiles data and prepares results for review
• Performs other duties as assigned in support of QC Laboratory operations such as facilities qualification, as well as QC testing, data review, sampling, and maintaining QC laboratory systems
• Assists in equipment and instrument qualification, calibration, and preventive maintenance, as assigned

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• BS or BA in Microbiology, Biological sciences, or related fields experience
• Minimum 2 years of experience and knowledge in the pharmaceutical and/or biotech industry in sampling and testing of critical utilities and environmental monitoring within a GMP environment
• Strong technical writing skills
• Execution of complex microbiological methods such as gram-staining, and microbial identification to species
• Extensive experience performing USP testing such as MLT, growth promotion, endotoxin, TOC and conductivity
• Must be able to gown as required in Production and QC Laboratory areas
• Strong aseptic technique experience
• Advanced knowledge of cGMPs, safety, proper documentation, and data integrity
• LIMS (Laboratory Information Management System) experience is preferred, but not required.
• Knowledge and application of GMP principles, and working in an FDA regulated environment
• Strong communication skills: oral/written and listening
• Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
• Interpersonal skills: team building, consensus building, conflict resolution
• Critical analytical skills, strong verbal and communication skills
• Ability to work independently in conducting quality system and process audits.
• Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
• Excellent presentation skills, including written and verbal communication skills

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.