Assistant Manufacturing Associate - Limited Term Hire
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.
Execute tasks per cGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing training program. Actively incorporate the Shared Values set out by Emergent BioSolutions while performing day to day activities.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Complete training and demonstrate competency on Assistant Technician qualification blocks in accordance with the training progression pathway
• Execute and document procedural steps in compliance with cGMP standards, clean room behavior and Standard Operating Procedures
• Comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations and company regulations such as the employee handbook
• Maintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing areas per Standard Operating Procedures
• Review all documentation for accuracy and completeness of process signature steps as each step is completed. Perform “real time” review of all documentation (BPRs, forms, logs, etc.) in the area throughout the shift
• Stock gowning and consumable supplies in the controlled areas maintaining Just-In-Time inventory (JIT) control of manufacturing materials
• Follow standard work guidelines
• Collaborate with applicable Integrated Process Teams to participate in continuous improvement and learn new Lean concepts
• Actively participate in kan ban and 6S programs
Inspection and Packaging
• Acknowledge GMPH alarms and perform appropriate follow up to ensure impact to product is minimized
• Successfully complete inspector qualification requirements to identify, classify and cull product defects, including those defects which could impact patient safety (inspector qualification)
• Independently operate labeling equipment with minimal supervision (Qualification)
• Apply traceability and expiration information to secondary packaging components such as cartons and cases. Confirm suitability of secondary packaging components during printing processes through 100% inspection (carton printing, case creation)
• Package product in secondary and final packaging components while performing 100% reconciliation of product rejects (Packaging)
• Action Oriented – Identify and seize new opportunities
• Resilient – Displays a positive attitude despite adversity
• Builds Networks – Build strong networks and maintain relationships across the site
• Collaborate – Partner with others to get work done
• Communicates Effectively – Effectively communicate with all levels of manufacturing and encourage the open expression of diverse ideas and opinions
• Courage – Readily tackle tough assignments and support others who do the same
• Customer Focus – Establish and maintain effective customer relationships
• Decision Quality- Rely on analysis, wisdom, experience and judgement when making decisions
• Accountability - Follow through on commitments and take responsibility for actions
• Manage Complexity – Acquire data from multiple and diverse sources when solving problems
• Manage Conflict – Works out tough agreements and settles disputes equitability
• Optimize Work Processes – Seek ways to improve processes, from small to larger improvements
• Self-Development – Learn from new experiences and show personal commitment to continuously improve
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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• HS Diploma
• 0-1 years experience working in a cGMP environment
• Knowledge of cGMP and CFR requirements preferred but not required
• Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Culturally aware
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.