Apex Systems is seeking Manufacturing Support Associates for one of our Bio-Pharmaceutical clients located near Willow Grove, PA. The ideal candidate will have 1-2 years+ of experience in a GMP environment.
The Manufacturing Associate I, Manufacturing Support Services works in a hands-on capacity in the cGMP production support areas (buffer preparation, equipment cleaning, etc.) to support manufacture of bulk drug substance (BDS). This role is responsible for supporting necessary production and production-related activities, including validation and development work as needed.
- Performs daily weigh/dispense, buffer preparation, and other process support operations for cGMP manufacture of CCH BDS.
- Works in a hands-on capacity to prepare buffers for purification and fermentation production steps as per manufacturing schedules.
- Enters/updates data into compliance documents and computer applications.
- Assists with and executes process, equipment, and cleaning validation protocols.
- Assists in the resolution of manufacturing deviations/non-conformances.
- Assists with troubleshooting processes and equipment.
Education and Experience:
- High school diploma is required with a minimum of 0-3 years working in biopharmaceutical cGMP commercial or late-stage clinical manufacturing environment, or equivalent relevant experience.
- General knowledge of cGMP practices, ICH guidelines, and validation practices.
- General knowledge of chromatographic and UF/DF principles.
Skills and Abilities:
- Ability to follow schedules and work plans, and coordinate with manufacturing groups to provide timely support.
- Ability to work well with others and establish working relationships with Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing.
- Exhibits attention to detail, accuracy in work, and integrity of character.
- Self-starter, shows willingness to learn and problem-solve.
- Has technical aptitude to learn and operate production equipment.
- Ability to stand for long periods of time.
- Ability to wear a sterile gown and shoe covers on a daily basis.
- Ability to lift 40 pounds.
For immediate consideration, please email a copy of your resume to [Click Here to Email Your Resumé]
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