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.
The Quality Specialist II is responsible for cross-functionally supporting investigations and quality documentation and providing QA oversight of each Quality System in support of commercial product manufacturing. This position will also support the CAPA, Change Control, and the Risk Management programs at the Emergent Canton site. Own and manage the Risk Register program at the site.
The Quality Specialist II will provide a broad scope of technical knowledge regarding quality systems and quality compliance. They apply their expertise and knowledge to provide quality oversight to cross-functional projects involving Quality Systems.
II: Responsibilities (Include key responsibilities only. This should not be an all-encompassing list)
• Own and manage the deviation quality system process.
• Prepare functional and management review metrics for identification of negative trends.
• Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team.
• Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product.
• Develop and manage CAPAs, Change Controls, and Risk Management process
• Provide QA review and oversight to individual CAPAs, Change Controls, and Risk Management program.
• Own and manage the Risk register program at the site.
• Responsible to perform timely complaint investigations as required by QA management.
• Perform SOP generation, review, and/or approval.
• Perform any other related duties as assigned by management.
• Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals.
• Lead or assist in continuous improvement projects as assigned, interact with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
Bachelor’s Degree in Scientific or related fields
A minimum of eight (8) years of cGMP Quality experience
Experience in cGMP manufacturing facility required
Experience owning deviations, CAPAs, and Change Controls is required
Experienced with US, EU, and Canadian pharmaceutical regulations, ISO standards
Expert knowledge and application of GMP principles
Excellent communication skills: oral/written and listening
Excellent facilitation and presentation skills
Personal Competencies: Self-awareness, integrity, judgment, vision, adaptability, decision making, and coaching
Interpersonal skills: team building, consensus building, conflict resolution
Critical analytical skills, strong verbal and communication skills
Must be able to critically evaluate data summaries and conclusions
Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
Ability to influence without authority across cross-functional organization
Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.
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.