The Manufacturing Associate Level I is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.
Key Accountabilities:
Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate.
Attain qualification for all assigned tasks and maintain individual training plan.
Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.
Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
Maintain facility and equipment through routine cleaning and sanitization, support 6S programs.
Qualifications:
Degree Required: High School Diploma Degree (preferred): AS/BS Years of Experience: 0-4 Years
Competencies & Behaviors :
Agility:
Demonstrates an ability and desire to learn from experience
Treats errors as a learning opportunity
Is willing to take on new challenges
Takes steps to adapt thinking and behavior to support change
Supports a culture of process improvement and problem solving
Demonstrates an openness to trying new approaches
Business Acumen:
Seeks to understand the corporate strategy and how his/her business area contributes to the company s success
Understands the impact of his/her own actions on his/her business area
Expresses ideas that will improve his/her business area
Uses knowledge of his/her business area to make accurate and timely decisions
Collaboration:
Works as an active member of his/her team
Generously shares information and knowledge with others on team
Demonstrates an openness to different perspectives by balancing listening and speaking
Treats all co-workers and customers professionally and with respect
Customer Focus:
Understands what internal and/or external customers need from him/her to deliver in his/her respective role
Demonstrates an openness to receiving customer feedback
Takes action to enhance customer satisfaction within the scope of his/her role
Driving Results:
Consistently delivers goals while monitoring KPIs with supervisor
Demonstrates persistence and motivation to overcome obstacles and challenges
Ensures quality standards are maintained while delivering results
Plans, prioritizes, and organizes work to deliver on time
Leadership:
Takes responsibility for his/her safety and that of others
Takes responsibility for personal choices and behaviors
Seeks feedback and reflects on his/her development needs in order to continuously improve
Contributes to a positive work environment
Acts as a reliable and dependable member of the team
Responsibilities:
Budget:
Accurate and timely completion of timesheets. Contribute ideas for cost savings where applicable, handle equipment and materials properly to mitigate potential damage / cost.
Quality:
Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
Safety:
Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety and the safety of others.
Skills:
Proven logic and decision making abilities, critical thinking skills
Strong written and verbal communication skills are required
Numbers & Facts
Location
Portsmouth, NH
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Skills
Administrative Skillsunmatched
Application Programming Interface (API)unmatched
Asepsisunmatched
Business Skillsunmatched
Business Strategyunmatched
CIP (Clean-in-Place)unmatched
Cleaning Equipmentunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Customer Relationsunmatched
Customer Satisfactionunmatched
Customer/Client Researchunmatched
Documentationunmatched
Documentation Reviewunmatched
Equipment Maintenance/Repairunmatched
Establish Prioritiesunmatched
GMP (Good Manufacturing Practices)unmatched
Laboratory Testingunmatched
Leadershipunmatched
Manufacturingunmatched
Performance Metricsunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Product Testingunmatched
Production Controlunmatched
Quality Metricsunmatched
Regulationsunmatched
SIP (Session Initiation Protocol)unmatched
Safety Complianceunmatched
Safety Processunmatched
Safety Trainingunmatched
Safety/Work Safetyunmatched
Standard Operating Procedures (SOP)unmatched
Time Managementunmatched
Writing Skillsunmatched
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