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 Production Supervisor will be responsible for execution of production fill activities associated with a new RABS (Restricted Access Barriers System) fill line, including development of procedures and subsequent training of operators, supporting execution of qualification activities, and ensuring compliance with safety standards and established policies and procedures. This role requires the following skills: good written and oral communication skills, the ability to lead a group, leadership through inspiring and motivating the team, the ability to provide and accept feedback, strong problem solving skills, the ability to identify and resolve issues in a timely manner, a willingness to make decisions and apply proper judgment based on sound, accurate information, flexibility and the ability to maintain effectiveness when experiencing major changes in work schedule and priorities, the ability to handling multiple tasks and projects at the same time, and good time management.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Monitor and ensure compliance by all personnel with cGMP regulations, Company policies, and SOP and Batch Record directions. Maintain a high degree of visibility and access to employees throughout the shift.
• Responsible for development of procedures and batch records associated with aseptic filling operations and subsequent training of operators.
• Provide technical expertise and support for execution of qualification activities.
• Review documentation, including executed batch records, and ensure that it complies with Good Documentation Practices.
• Coordinate, schedule, and oversee Aseptic Filling activities.
• Interface with the Quality Assurance; Facilities and Maintenance; Materials Management; and Manufacturing, Science, and Technology departments to resolve production, supply, and equipment issues. Document issues through deviations and assist with investigations, as necessary.
• Utilizes and continuously improves Operational Excellence standards (i.e. 6s, standard work, problem solving, Process confirmations, and performance management) towards the goal of Zero Accidents, Zero Defects, and Zero Waste.
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
• BA/BS in science or technical field with minimum of 3 years experience in cGMP or regulated environment.
• Or High School/AA with a minimum of 8 years experience in cGMP environment.
• 3 years previous supervisory experience in cGMP environment preferred.
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.