Manufacturing Specialist 3

• Qualified to participates in the aseptic processing of in-house made solutions as well as all patient processes according to cGMPs

• Reads, understands, and follows Standard Operating Procedures (SOPs)

• Assists in the training and mentoring of new staff

• Sets up and operates production equipment, i.e. control rate freezer, orbital shaker, etc.

• Assists in deviation and CAPA investigations, and compiles data/information related to internal investigations as required

• Routine logbook review

• Revises approved documents as required including SOPs, batch records, and/or MS forms

• Perform routine transactions with the ERP system including, but not limited to material requisitions and production tracking

• Complete GMP documentation, including batch records, logbooks, forms, etc. according to GDP

• Support the maintenance of the clean room environment in order to maintain the cleanroom below alert level limits by following established procedures

• Is knowledgeable and complies with all pertinent safety policies, rules and regulations.

• Ensure that all team members comply with safety rules and regulations.

• Able to perform procedures according to written guidelines and recognize a deviation from accepted practice.

• Relies on instructions and pre-established guidelines to perform the functions of the job.

• Perform material qualification tests in order to qualify lots of incoming manufacturing material

• Process development support as needed

• Data collection and compilation as needed

• Perform other duties as assigned

Requirements

Description

Education/Training

AS/BS in Biotechnology, Biology, Chemistry, or equivalent

Preferred area of study: Science related discipline

High School Diploma or Equivalent may be considered with relevant experience

Experience

Minimum 4+ years relevant experience

Skills/Abilities

• Ability to exercise judgment within defined procedures and practices to determine appropriate action.

• Ability to read, understand and follow production schedule.

• Ability to read, understand and follow SOP's.

• Ability to understand importance of compliance with cGMP's.

• Ability to perform aseptic gowning on a daily basis.

• Ability to work independently as well as in a team setting

• Computer software skills including Microsoft Office

• Organization skills, record keeping, time management, regular attendance

Other

• Good eye/hand coordination

• Written and oral communication, team oriented, strong work ethic