Position Title:

Manufacturing Associate Level I Work Location:

Portsmouth

NH 03801

Assignment Duration:

12

Months Work Schedule:

B Night Shift 6:30 PM-0630AM alternating weeks (one week Mon/Tue/Fri/Sat/Sun; next week Wed/Thu)

Position Summary:

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.

Key Responsibilities:

• 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.
• Administrative tasks
• attending shift exchange, meetings, sending/receiving emails, participating in projects.
• Perform other duties as assigned.

Qualification & Experience:

• High School Diploma or Equivalent required.
• AS/BS in Science related discipline preferred.
• English
• Business Fluent required.
• Manufacturing
• Entry Level
• 0-4 years.

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.

• Proven logic and decision making abilities, critical thinking skills.
• Strong written and verbal communication skills are required.

Working Conditions & Physical Demands (If Applicable):

Environmental Demands:

The normal working environment is: Production Floor Setting requiring PPE, gowning, safety shoes and glasses.

Physical Demands:

Continuous

• Gowning, Standing; Frequent
• Bending, Kneeling, Climbing stairs, Climbing ladders, Walking, Reaching; Occasional
• Squatting, Sitting, Driving, Fine motor skills; Lifting 25lbs / 50lbs.

Mental Demands:

Must have the ability to comprehend process flow and identify factors which influence the process. Must be able to read and follow defined SOPs and policies, work independently on basic manufacturing tasks, identify and communicate non-routine events, and review more complex decisions with Supervisors. Must be able to use automated process equipment and tools.

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.

Quality Responsibility:

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