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
This role is responsible for monitoring Quality Control laboratories, reviewing GMP records/data, and interacting with Batch Review, Quality Control, and Quality Engineering teams to provide guidance necessary to maintain and improve CGMP compliance at the facility.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Conduct Analytical and Micro Labs in-process audits and walkthroughs
• Perform Quality on the Floor batch record review
• Monitor key Quality Control laboratory processes
• Review logbooks, reports, data integrity, equipment audit trails, and GMP records
• Participate in daily QA and QC tier meetings
• Maintain company quality and safety standards in the labs
• Author/revise standard operating procedures (SOPs) and other controlled documents
• Support QC Quality on the Floor improvement initiatives
• Implement solutions for issues affecting QA and Quality Control operations
• Initiate deviations and assist in area investigations
• Train/mentor QC personnel to resolve open concerns resulting from record reviews, walkthrough observations, and deviations
This will be a day shift Monday thru Friday position. Overtime and weekend work may be required based on business needs.
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 management's 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
BS or BA degree in Science or Engineering with 2-5 years of GMP experience; QA/QC role preferred
• Ability to make sound compliance-related decisions with minimal supervision
• Must possess strong attention to detail.
• Ability to navigate lab equipment software and computer programs such as Veeva (Document Management System) and SAP (ERP System).
• Proficient knowledge of CGMP.
• Strong communication (written and verbal) and organizational skills.
• Ability to independently manage multiple priorities in a dynamic environment.
• High level of personal/departmental accountability and responsibility.
• Excellent problem-solving and teamwork skills.
• Proficient at resolving issues in creative and innovative ways.
• Exercises good judgment in selecting methods/techniques to achieve positive results.
• Understand and respond appropriately to a diverse population.
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.