Analyst III, Quality Assurance

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.
I. JOB SUMMARY
The Analyst III, Supplier Quality Assurance supports the state of compliance at the Camden and MDCW facilities through day-to-day operation of the Supplier Quality Management program at the site level.
II. ESSENTIAL FUNCTIONS
• Supplier Quality Management (SQM)
o Partner with Supply Chain and Global Supplier Quality teams to execute required activities for the qualification and monitoring of suppliers.
o Evaluate new supplier requests and maintain the Approved Supplier List to ensure supplier information is up-to-date and accurate.
o Identify the need for site level Supplier Quality Agreements, track and initiate their renewal.
o Subject Matter Expert for Veeva SQM module.
o Responsible for working with the purchasing department and collaborating on supplier corrective actions requests (SCARs) as needed for non-conforming materials.
o Follow up with supplier to ensure implementation of appropriate CAPAs identified through SCAR process.
• Material Management
o Perform/support performance of elemental impurity and EU risk assessments, upon request.
o Manage the assessment and implementation of supplier-initiated change notices (SICNs) related to local suppliers.
• External Supplier Audits
o Communicate with Global Supplier Quality team to monitor schedule and execution of audits of suppliers supporting the Camden and MDCW facilities.
• Owns, approves, and participates in CAPAs, deviations, and change controls related to the above functions
• Revises Standard Operating Procedures and forms, as needed.
• Support other activities within the QA department, which may include providing compliance metrics for site and corporate management, supporting regulatory inspections, client audits, annual product reports and other quality or regulatory activities as needed.
• Resolves a wide range of issues in creative ways. Defines appropriate actions and requirements for resolution of issues.
• Clear understanding of related SOPs, cGMPs and regulations necessary to accomplish daily tasks.
• Maintains company quality and safety standards.
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
• BS degree in Chemistry/Biology or related discipline with 5+ years relevant experience in a regulated manufacturing industry, preferably pharmaceuticals or medical device.
• cGMP Compliance - Required to be trained on all related GMP SOPs and must abide by the rules and regulations associated with the maintenance of these documents. GMP regulatory knowledge based in US, European, and other countries a plus. Ability to assess and mitigate risk as it relates to supplier impact at the site.
• Computer skills - Experienced with Microsoft Office suite. Experience with Veeva, SharePoint, and other software systems a plus.
• Demonstrated success in independent judgment, technical proficiency and collaboration with others in a cGMP environment.
• Must be a team player and able to work cross-functionally in a matrixed environment.
• Must have strong attention to detail.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Must have excellent written and verbal communications skills.
• Excellent organizational and interpersonal skills.
• High level of personal/departmental accountability and responsibility.
• Ability to exercise judgment to determine appropriate corrective actions.
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
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.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
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 actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.
WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder no matter what
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • Every person at Emergent is engaged and accountable for delivering on our commitments.
• Break through thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.