QC Microbiology Analyst I, Testing
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.
This is a laboratory testing position with the major responsibilities being daily routine testing and laboratory maintenance tasks. Additional responsibilities involve quality systems support.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Technical Expertise:
- Basic understanding of compliance/guidance/regulation pertaining to assigned area.
- Performs routine testing following written procedures and limited non-routine testing including validation studies with supervisory oversight.
- Performs testing competently in at least one to two areas of microbiology, bioassay, or chemistry testing using aseptic and microbiology techniques, such as, but not limited to:
- Microbiological Examination – purity test, filtrate, bacterial endotoxins test,
- Aseptic Technique
• Laboratory Support (Including Quality Systems):
- Identifies and supports change and continuous improvement using LEAN practices such as 5S and Kaizen.
- Conducts peer review (second-person check of QC data).
- Verifies and enters passing results in laboratory information management systems (LIMS).
- LIMS administration functions such as job and sample creation.
- Monitor controlled temperature units.
- Receive, label, and restock reagents and supplies.
- Demonstrates proficiency in the use and maintenance of standard laboratory equipment.
- Works with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment.
- Maintains the lab and associated areas using the LEAN 5S concept.
- Quality Systems:
- Provide input to SOP / Test Method revisions.
- Participates in laboratory investigation, deviation, CAPA, and Change Control activities.
• Problem Solving
- Works on problems of simple to moderate scope in which analysis of situation or data requires a review of identifiable factors.
- Exercises judgement within defined procedures and practices to determine appropriate action.
- Follows good microbiology laboratory practices and procedures in analyzing situations or data from which answers can be readily obtained.
- Receives general instructions on routine work, detailed instructions on new assignments.
• Behavior/Cultural Responsibilities:
- Ownership – Actively participate in self-development (SLII, IPMP)
- Accountability – Follow through on commitments (PIL, Situational Leadership or additional accountability tools)
- Detail oriented – Able to complete required tasks and associated documentation with minimal error
- Adaptability – Maintain positive attitude in a changing work environment
- Communication – Effectively communicates with all levels of manufacturing and support staff
- Actively participate in department level meetings
- Escalate issues through the proper channels
- Live the Core Values
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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor's degree in an applied science.
• 0-2 years' experience preferred, or equivalent level of skill and experience.
• Previous experience with microbiology assays and aseptic techniques in a GMP manufacturing environment is preferred.
• Personal Competencies: self-awareness, integrity, team player, innovative, and flexible.
• An understanding of cGMP, CFR, USP, and aseptic processing guidelines is preferred.
• Computer skills (MS Office, MS Project) or comparable word-processing and spreadsheet applications is required.
• May require work on weekends, and nights.
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.