Position Title:

Manufacturing Associate Level I Work Location:

Portsmouth, New Hampshire 03801

Assignment Duration:

6 months

Work Schedule:

Day Shift 6AM - 6PM One week is Monday Tuesday Friday Saturday Sunday, and the next week is Wednesday Thursday. 0600 - 1800.

Work Arrangement:

Onsite 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. 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.

Background & Context:

Supports manufacturing of therapeutic proteins (API) in a cGMP production environment for The Organization.

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.
Entry Level - 0-4 years Manufacturing experience.
English Ability Level 2 - Business Fluent.
Proven logic and decision making abilities, critical thinking skills.
Strong written and verbal communication skills are required.

Working Conditions & Physical Demands:

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

Physical Demands:

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

Travel:

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