Specialist I, QC Microbiology
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I. JOB SUMMARY
Responsible for generation, tracking, and completion of quality investigations and compliance records for the QC department. Responsible for tracking and trending of QC data for reporting and improving processes based on trends.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Assesses compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
• Assists with execution, documentation and review of testing as required to support product release, stability, and validation studies.
• Leads or coordinates complex projects, potentially interacts with other department personnel to accomplish objectives.
• Helps management to lead LIR, OOS, and QC based deviations investigations; designs and implements corrective action plans to address deficiencies.
• Ensures the reliability and accuracy of the computer databases, and paper files.
• Writes proposals and/or summary documents suitable for external distribution or for regulatory submission that collaborate data from multiple sources.
• Provides technical and scientific assistance/expertise as required to clarify and troubleshoot scientific challenges internally or in collaboration with other departments as a member of a cross-functional team.
• Provides information in support of department budget. Contributes to departmental strategy and provides input on lab requirements and improvements.
• Assists with reduction of human error deviations by improving existing training methods
• Trends QC data for analysis and reporting
• Performs QC Microbiology data review of in-process, release, and stability testing data to support a GMP facility and manufacturing.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor’s degree in biology, chemistry, or related field of study.
• Minimum of 8 years directly related experience in the pharmaceutical/biopharmaceutical or related industry.
• Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
• Proficient and professional communicator, verbally and in writing.
• Demonstrated technical competence; can analyze data and interpret results to make scientifically valid conclusions.
• Strong organizational and interpersonal skills and the ability to work collaboratively with others.
• Proficient in complex procedures and problem solving.
• Strong commitment to teamwork, proven leadership skills, independence and initiative.
• Extensive knowledge of Microbiology testing, Environmental Monitoring, Endotoxin, Bioburden, MLT, USP/EP testing, etc.
• Proficient in Microsoft Office - Word, Excel, PowerPoint.
• Comprehensive knowledge of pharmaceutical GLPs and GMPs.
• Comprehensive knowledge of laboratory techniques and safety precautions.
• Comprehensive knowledge of regulatory/industry guidance.
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
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.
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.