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 Operations Specialist is responsible for direct support of process improvement and compliance directives associated with the manufacturing activities at the Emergent Camden facility.
Direct performance of process deviation investigations, supporting corrective/preventive action (CAPA) creation and ownership, and change control generation, ownership, and execution in support of all Emergent Camden manufacturing processes.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Individual will be liaison between Quality Assurance and other departments to ensure Manufacturing commitments are completed in a compliant manner. They will operate in a cohesive fashion.
• Required to work with some supervision by senior staff and with other departmental or non-departmental personnel.
• Investigation and writing of non-conformances such as deviations, complaints, OOS, OOT, deviations, etc.
• Reviewing process, product and equipment related validation and stability protocols and reports
• Technical review of SOPs and processes
• Developing and implementing process improvements
• Participates in Manufacturing Process Improvement Teams
• Other assigned responsibilities as established by Manager.
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 Engineering, Business/Operations, or related discipline with 4-6 years GMP experience required, 2-3 years production supervision experience desired.
• MS or MBA degree in Engineering, Business/Operations, or related discipline with at least 2 years Manufacturing experience may be substituted.
• Ability to make sound decisions regarding compliance-related issues with moderate supervision.
• Must have strong attention to detail.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Strong communication skills (written and verbal) and strong organizational skills.
• High level of personal/departmental accountability and responsibility.
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to use computer programs such as Access, Excel, SAP and an electronic document management system.
• Ability to work in a team environment and to work within that team to maximize efficiency and throughput.
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.