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
The Quality Control Data Services Analyst will provide direct support to Quality Control personnel for authoring OOL investigations, authoring Environmental Monitoring/Personnel reports, authoring product testing reports, maintaining the microorganism reports from an outside contractor, become gown qualified to enter the Grade A areas, maintain the gown qualification/media fill databases by alerting personnel when they are due for their qualification, and may perform environmental monitoring/testing as needed.
This position will work closely Microbiology Laboratory Management.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Author the EM/Personnel Monthly and Yearly Reports
Author OOL investigations for filling operations and the facility.
Author product testing reports (B/F, BMQ, and E/I) for Microbiology.
Become gown certified to enter the Grade A areas of the facility to assist with investigations.
Maintain the gown certification and media fill participation lists. Also, send out email communication for when people are becoming due.
Perform trends of Microbiology Data for deviations written by QA.
Perform environmental monitoring and testing as needed.
Maintain the list of training for the Microbiology lab for annual sterility testing requalification, colony counting and live culture training.
Track time worked per project.
Participate in and attend professional seminars, conferences and conventions.
Participation in biomedical screening is required.
Site Support and Continuous Improvement:
Uses GMP and scientific expertise to support internal and external audit activities
Participates in change and continuous improvement through LEAN practices such as 6S and Kaizen
Provide basic support during regulatory inspections
Serve as analyst for demonstration of methods or techniques for auditors
Support response teams for observations and recommendations
Ownership Actively participate in self-development
Accountability Follow through on commitments
Detail oriented Able to complete required tasks and associated documentation with minimal error
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 managements assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
To perform the job successfully, an individual should demonstrate the following competencies to perform the essential functions of this position.
Technical/Professional Knowledge having achieved a satisfactory level of technical and professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise.
Problem Solving the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully.
Safety and Securitythe individual observes safety and security procedures and uses equipment and materials properly. May be required to lift items that are approximately 25lbs.
Communication the individual speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings.
Quality Management the individual looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
Planning/Organizing the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
Adaptability maintains effectiveness when experiencing major changes in work tasks or the work environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
Stress Tolerance maintaining stable performance under pressure or opposition (such as time pressure or job ambiguity); handling stress in a manner that is acceptable to others and to the organization.
Education: BS in Microbiology/Biology or related field
Experience: Minimum 2-4 years (MS with 0-2 years) in the Pharmaceutical or Biotechnology with emphasis in one of the following areas: aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes.
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.ABOUT EMERGENT
Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES
- Stand shoulder to shoulder no matter what
- We combine our best thinking and communicate openly to support each other.
- Break through thinking
- We take smart risks, pursue innovation and challenge ourselves to constantly improve.
- Own it always
- Every person at Emergent is engaged and accountable for delivering on our commitments.
- Compete where it counts
- We set the right goals and respect each other as we conquer them together.