What are the responsibilities and job description for the Drug Product Manufacturing Associate II position at Amtec Inc.?
This is a Temporary to Direct Role
Carlsbad, CA.
Pay Range: $23.00-$28.00
This role is 100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 7:00 am - 9:00 am with a consistent schedule.
Position and Scope
The purpose of this position is to perform tasks and operations relevant to the bulk formulation and/or filling operations required for sterile production of liquid injectable pharmaceutical products under cGMP regulations in Drug Product Manufacturing.
Duties And Responsibilities
Carlsbad, CA.
Pay Range: $23.00-$28.00
This role is 100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 7:00 am - 9:00 am with a consistent schedule.
Position and Scope
The purpose of this position is to perform tasks and operations relevant to the bulk formulation and/or filling operations required for sterile production of liquid injectable pharmaceutical products under cGMP regulations in Drug Product Manufacturing.
Duties And Responsibilities
- Performs various routine manufacturing tasks under the direction of internal SOP's and cGMP guidelines.
- Prepares material components for manufacturing operations
- Documents steps clearly and completely in production batch records, logbooks and other controlled forms
- Participates in inspection readiness activities.
- Performs basic arithmetic and algebraic computation
- Maintain cleanliness of areas and equipment
- Performs bulk drug formulation using a variety of lab equipment including mixers, balances, pH meters, etc..., gowned in accordance with Class C (ISO 7) conditions
- Performs sterile filtration activities, gowned in accordance with Class C (ISO 7) conditions
- Performs sterile filling of a multitude of solutions including drug product, media, buffers, using an automated filling and closing machine, gowned in accordance with Class C (ISO 7) conditions
- Participates in the execution of validations/qualifications of new processes and equipment
- Collects and disposes of lab wastes according to established procedures
- Collaborate in continuous improvement activities
- High School Diploma or Equivalent with 2 - 4 years relevant experience is required, a Bachelors in an Engineering Discipline or Life Science Field preferred.
- Time and project management skills with the ability to multi-task are essential.
- Must be able to effectively communicate within department and cross functionally with other divisions.
- High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction.
- Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business is a plus.
Salary : $23 - $28
