We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
The Quality Assurance Analyst 1 is an entry level quality professional that is responsible for Quality oversight of processes in manufacturing/ production and/or release laboratories.
This position interacts with Manufacturing, Quality Control, Production Planning, Emergent partners and Auditors/Inspectors to ensure required inputs for the manufacturing process meet cGMP requirements within established timelines.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Provide direct quality “on the floor” support and oversight to with oversight from QA management
• Follows written instructions in the routine review of laboratory and production records in accordance with Emergent standard operating procedures and good documentation practices (GDP)
• Perform label control processes such as counting, verification, issuance, receipt and reconciliation of components
• Supports Minor Non-conformance investigations which may contain basic root cause analysis
• Uses existing procedures to solve routine or standard problems
• Basic conceptual knowledge and practices associated with Document Review and Product Disposition
• Recognizes errors in records and resolves them in a timely manner
• Supports basic improvement projects
• Has limited decision-making authority; works within technical guidelines and direction to achieve objectives and meet deadlines.
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
• BA/BS (in an applied science preferred) or equivalent work experience.
• 1-3 years of experience working in an FDA regulated industry preferred
• Experience with quality assurance preferred
• Gowning for BSL-2 and BSL-3 and Aseptic environments preferred
• Candidate must exhibit strong interpersonal and communication skills, strong oral and written communication skills
• Ability to make sound decisions regarding compliance-related issues with supervision
• High level of personal/departmental accountability and responsibility.
• Familiarity with pharmaceutical industry guidance (ICH, CFR 21.210-211, USP)
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
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.