Specialist I (2nd Shift)
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 QA Specialist I On the Floor is responsible for assuring the quality of products manufactured at the Emergent BioSolutions Baltimore Facility. The QA Specialist I on the Floor will perform Quality on the floor functions. Our QA Department provides expertise in problem solving and process improvements. The QA Analyst will interact with manufacturing personnel and the Quality Engineer to provide guidance necessary to maintain and improve CGMP compliance at the company.
Key Duties will include:
- Quality at the source utilizing on the floor real time batch record review, disposition and in process auditing.
- Performance of walkthroughs of GMP areas to ensure inspection readiness of facility is maintained. Includes the documentation, follow up and escalation of observations and areas of concern.
- QA oversight of manufacturing processes. Provides quality guidance to manufacturing personnel to manage resolution of in-process deviations.
- Write and revise Standard Operating Procedures (SOPs).
- Review and approval of GMP documents such as batch records, engineering runs, work orders, logbooks, and reports to ensure compliance with specifications, regulations and procedures.
- Makes recommendation to Quality Assurance Management for the release of product based on Quality Assurance record review and approval.
- Actively involved in daily operations to meet schedules and to resolve problems.
- Demonstrate strong organization skills related to priorities and work load. Ability to solve problems independently and within a team environment.
- Train and mentor production personnel on manufacturing processes to resolve open issues resulting from record reviews, on the floor walk through activities, and deviation issues.
- Write, reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking and follow-up plans.
- Implementation of solutions for identified issues affecting daily manufacturing operations.
- Represents Quality Assurance to guide various project and technical meetings, as needed.
- Support and manage existing and/or develop and implement new programs, processes designed to drive continuous improvement.
- Review and approval of Standard Operating Procedures (SOPs), and Master Batch Records (MBRs) on eDocs.
- Supports and Assists Quality Systems on timely closure of CAPA’s, Gap Analysis and Product Complaints.
- Track and trend metrics for QA on the Floor audits, Logbook audits and In-Process Audits metrics on a monthly basis for Senior Management.
- Delivered a structured approach to oversight the aseptic operations for all filling lines including cleaning processes.
- Be present in the fill rooms to perform real time feedback, correction and review of aseptic operations.
- Document the oversight results as required by current standard operating procedures and corresponding GMP forms.
- Report results of the aseptic operations oversight on a frequently basis for the Senior Management of the areas involved.
- Coach and mentor personnel working the aseptic core including but not limited to Operations, Microbiology and Engineering personnel to foster a climate of routine inspection readiness.
- 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 manufacturing needs.
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.
Education, Experience & Skills
- BS or BA degree in Science or Engineering with 5-10 years of GMP experience.
- Must have strong attention to detail.
- Ability to manage multiple priorities and tasks in a dynamic environment.
- Excellent written and verbal skills.
- Ability to exercise judgment to determine appropriate corrective actions.
- Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
- Ability to use computer programs such as eDocs and SAP.
- Ability to work in a team environment.
- Proficient knowledge of CGMP.
- Coordinate multiple tasks simultaneously.
- Understand and respond to a diverse population.
- Gowning certification required.
- Ability to make sound decisions regarding compliance-related issues with moderate supervision.
- Strong leadership skills; high level of personal/departmental accountability and responsibility.
- Minimum of one year in a FDA regulated industry.
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.
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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.