Specialist I, QA on the Floor - Packaging, 2nd Shift
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 QA Specialist I role is responsible for assuring the quality of products manufactured, Packaging & Inspection Operations support, CGMP compliance, Quality on the Floor continuous improvement, and client satisfaction.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Perform product and labeling visual over-inspections
• Conduct GMP area in-process audits and walkthroughs
• Complete Quality on the Floor batch record review
• Review and approve GMP records
• Participate in daily tier meetings with site partners
• Partner with Operations to meet schedule requirements and resolve challenges
• Support / assist timely closure of CAPAs, gap analyses, and product complaints
• Maintain company quality and safety standards
• Author and revise standard operating procedures (SOPs)
• Lead Packaging Quality on the Floor improvement initiatives
• Train new Pkg Quality on the Floor personnel on related procedures
• Initiate deviations and assist in area investigations
• Track and trend Pkg QOTF data for monthly metrics reporting
• Train Packaging & Inspection personnel to help resolve issues
This will be a 2nd shift (2:00 pm to 10:30 pm) Monday thru Friday position. Overtime and weekend work required, as needed, 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 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 relevant field with 5-8 years of GMP experience required; QA/QC role preferred
• Ability to make sound compliance-related decisions with minimal supervision
• Must possess strong attention to detail.
• Ability to navigate 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.
• Creatively use business concepts and company policies/procedures to solve problems.
• Excellent complex 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
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.