Position Summary
The Manufacturing Associate I, is a contract employee in a full-time non-exempt position. This employee will be responsible for the manufacturing of Drug Substance, Drug Product, visual inspection, and Secondary Packaging for clinical and commercial products for human use. Employee employs aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Must comply with policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirements.
Essential Duties & Responsibilities
Will be assigned to the daily operations, working with:
Weighing and dispensing of material
Operation of Glasswasher and autoclave
Media and buffer preparation
Drug Substance manufacturing
Filtration systems
Aseptic filling of glass vial and pre-fillable syringes.
Visual inspection of glass vial and prefilled syringes
Responsible to train and follow aseptic practices in ISO 6 area.
Responsible to participate in media fill operations.
Responsible for secondary packaging, material issuance and visual inspection.
Responsible for in-process testing, such as: pH, Conductivity etc.
Will verify all raw materials and commodities.
Completes Batch Records and other cGMP documentation accurately and in a timely manner.
Removes and dispose soiled materials from the manufacturing area.
Will assure that the manufacturing areas are maintained within the required conditions for clean room manufacturing.
Will report all nonconformance or events that arise during the shift to the Supervisor.
Complies with all safety, cGMP and Company policies, practices, and procedures.
Writes, reviews, and makes recommendations for change to cGMP documentation such as SOPs and Batch Records.
Assists with new employee training.
Supports coordination of activities as necessary.
Position Requirements and Qualifications
Education:
Undergraduate with relevant experience in GMP.
Associate degree in Science, major in Biology, Chemistry or Biotechnology with at least one year of experience in aseptic product manufacturing.
BS degree in a Biotechnology, Biology or Chemistry with one to three years of experience in pharmaceutical / biotechnology field.
MS degree in a Biotechnology, Biology or Chemistry with less than two years of experience in pharmaceutical / biotechnology field.
Experience:
1 to 3 years of experience in pharmaceutical / biopharmaceutical field.
Aseptic techniques and clean room manufacturing experience is preferred.
SPECIALIZED KNOWLEDGE AND SKILLS:
Language:
Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English.
Excellent interpersonal skills.
Reasoning Skills:
The candidate should have the ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.
Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes
Ability to work independently, within prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.
Computer and/or Technical Skills:
Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc.
Operation and understanding of word processing, spreadsheets, and data management
Knowledge of GMP and safety requirements.
Knowledge of biotechnology operations such as:, Aseptic Filtration Systems, Aseptic Sampling, Filter Integrity Testing, Fermentation Process, Inoculation Process, Chromatography Columns, Osmometer, Weigh Scales, etc.
WORK ENVIRONMENT AND PHYSICAL DEMANDS:
General Work Environment:
Manufacturing clean rooms
Willing to work in any of the three shifts or rotate Shifts and work weekends as required by the operations.
Noise:
Standard noise levels.
Standing/Lifting:
Extended periods of standing and walking while working in the manufacturing areas
Must be able to lift 25 lbs.
Visual:
Eye test for prescription safety glasses is required
No color blindness
Stress:
High paced demanding environment to meet ambitious project goals.
Travel:
Limited travel will be required, but not exceed 5%.
Employment Type: Contractor
Salary: $ 24.00 Per Hour
