MA
About The Position
Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record and control system. May coordinate or lead process steps as requested Documents/Records and Reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Revises or creates documents as instructed. Key documentation includes batch records, SLRs, and equipment logbooks. Actively participates in training activities, managing their individual training plan. Trains other associates as required. Executes validation protocols with minimal supervision/direction of others. Perform and document daily manufacturing operations in a cGMP environment. This involves operation of process equipment, execution of validation protocols, creating/ revising cGMP documents and other assignments. Applicants will be highly detailed oriented with excellent documentation skills. Applicants will become trained and skilled at most or all unit operations in their area, often leading the execution of procedures, and performs most functions with minimal supervision.
Requirements
- Detailed oriented with excellent documentation skills
- Operates in a safe manner in order to avoid injury to self and others
- Strong people skills
Nice To Haves
- Targeted biopharmaceutical training (Bioworks or equivalent) and/or related military training also preferred.
Responsibilities
- Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record and control system.
- May coordinate or lead process steps as requested
- Documents/Records and Reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures.
- Revises or creates documents as instructed.
- Actively participates in training activities, managing their individual training plan.
- Trains other associates as required.
- Executes validation protocols with minimal supervision/direction of others.
- Perform and document daily manufacturing operations in a cGMP environment.
- Operate process equipment
- Execution of validation protocols
- Creating/ revising cGMP documents
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
