BioProcess Associate-3rd-Shift
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Job Detail
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Offered Salary 0
Job Description
ESSENTIAL FUNCTIONS
•   Work under general supervision of more experienced Technicians or Manufacturing Supervisors to produce parenteral drugs.
•   Comply with cGMP regulations, adhere to established policies, SOP and Batch Record directions.
•   Complete all necessary documentation in a manner that complies with Good Documentation Practices as tasks are performed.
•   Independently set up, assemble, and operate all equipment necessary for the daily manufacturing of products, especially related to aseptic operations in the sterile core, in accordance with current industry, client, and established standards.
•   Effectively troubleshoot equipment during operation to ensure effective and efficient operations while maintaining high quality and service to the client.
•   Assist the Validation and Maintenance staff with the operation and execution of engineering projects.
•   Conduct training sessions for less experienced Technicians to ensure a high level of effectiveness and quality is met during production operations.
•   Perform housekeeping, plant upkeep, and sanitization activities throughout the production area as required.
•   Prepare clean or sterile equipment as necessary for routine aseptic operations
•   Maintain proper Gowning Qualifications necessary for routine aseptic operations, including filling operations, cleaning of ISO 5/6 areas, and loading/unloading Terminal Sterilization autoclaves and Lyophilizers.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
•   BA/BS in any field
•   Or High School/AA with at least 3 years of experience in a GMP environment
•   Ability to work independently with minimal guidance and as part of a team
Experience using computer applications, including data statistical, word processing, spreadsheet, and presentation software.