Manufacturing Associate II

Blue Ocean
Philadelphia, PA Contractor | Full Time
POSTED ON 4/15/2024 CLOSED ON 4/23/2024

What are the responsibilities and job description for the Manufacturing Associate II position at Blue Ocean?

Manufacturing Associate II

Overview:

Responsible for manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsibilities:

  • Understands aseptic technique concepts
  • Has performed aseptic technique, is able to identify unacceptable practices and make spot corrections to performance
  • Able to operate and maintain equipment
  • Understands the basic operations and functions of equipment and is able to perform basic troubleshooting
  • Performs solution and material preparation
  • Possesses basic technical knowledge and background in the industry
  • Possesses basic and fundamental engineering and mechanical knowledge
  • Possesses basic and fundamental facility start-up experience
  • Has participated in facility start-ups
  • Participates on and performs technical transfer activities
  • Assists with the execution of validation activities
  • Receives and organizes materials
  • Performs material procurement activities
  • Identifies, communicates and resolves material discrepancies
  • Uses most support systems (e.g. LIMS) with some demonstrated proficiency
  • Understands the concept of and has performed or experience with manufacturing processes and methods
  • Identifies and understands acceptable and unacceptable practices and is able to make on the spot corrections to performance
  • Collects, records, reviews, performs basic analysis and identify basic trends of scientific and process data per good document practices
  • Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and starts to understand ‘why’ behind the regulations
  • Follows and executes Standard Operating Procedures (SOPs)
  • Revises and authors simple SOPs
  • Follows and executes Batch Records (BRs)
  • Revises and authors simple BRs
  • Trains others on basic SOPs, equipment and unit operations
  • Participates and provides information in the development of technical documents such as non-conforming events and deviations
  • Possess basic computer skills and able to efficiently use basic Microsoft applications
  • Suggests and participates in continuous improvement ideas
  • Identifies, participates and suggests solutions to technical problems
  • Identifies, suggests and seeks out for decision making
  • Participates and supports regulatory inspections and client audits
  • Interacts on a minimal basis with groups that support manufacturing
  • Cross trains in other areas and may be utilized to perform above job functions across the entire site
  • Performs well under direct supervision and starts to work independently on basic tasks and processes

Job Types: Full-time, Contract

Pay: From $26.00 per hour

Schedule:

  • 10 hour shift
  • 12 hour shift
  • 8 hour shift
  • Day shift
  • Evening shift
  • Monday to Friday
  • Morning shift

Education:

  • High school or equivalent (Preferred)

Experience:

  • Manufacturing: 1 year (Preferred)
  • Cell culture: 1 year (Preferred)
  • Aseptic technique: 1 year (Preferred)
  • SOP: 1 year (Preferred)

Work Location: In person

Salary : $26

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