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Parts Technician

Company: Ion Idea
Location: West Chester
Posted on: June 12, 2021

Job Description:

Job Description

Ideal Candidate Profile:
-We are open to recent grads who are looking for an opportunity in pharma. We can also consider candidates with more professional experience, who have a strong skillset within product quality, inspection, or packaging.
-Pharma industry experience is nice to have, but not a must have requirement

Job Responsibilities:
Operate production equipment without supervision after certification.
Create, revise, and assist with preparation of documentation regarding activities, actions, and/or results.
Clean and sanitize equipment and components.
Complete duty-based packets by reading SOPs (Standard Operating Procedures) and excerpts from technical documentation.
Complete required training.
Ensure proper documentation practices during production.
Ensure that weights, measures, and raw materials are managed appropriately so that manufactured batches contain proper ingredients and quantities.
Initiate batches in SCADA.
Perform shift cleanings, including spot and more detailed cleanings.
Perform visual inspections.
Assist with troubleshooting and process improvement activities.
Participate in spill control, handling of hazardous materials, and first aid.
Use SAP to track inventory and materials.
Monitor production area to ensure compliance with regulatory requirements.
Review completed production documentation (for example: batch records, log books, etc.) for quality, completeness, and cGMP compliance.
Alert others (for example: supervisor, manager) when problems occur outside of SOPs (Standard Operating Procedures).
Attend team meetings to discuss progress, initiatives, and/or other matters.
Monitor equipment for performance and problem indicators.
Participate in daily shift change meetings.
Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, etc.
Wear sterile garments and PPE (Personal Protective Equipment) as required by specific activities.
Conduct process checks to ensure that processes are operating within required parameters.
Conduct environmental monitoring activities

Other Duties:
Train others on equipment, machines, procedures, and/or processes.
Write, review, and revise SOPs, work instructions, and MBRs (Master Batch Records) for cGMP (Good Manufacturing Practices) manufacturing of commercial product.

Minimum Requirements:
High school graduate, vocational school graduate or equivalent
1 Year of experience in a sterile pharmaceutical environment
Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.

Preferred Background:
Prior production experience
Experience working in a LEAN manufacturing environment
Knowledge of cGMPs and FDA policies/procedures

Keywords: Ion Idea, Cincinnati , Parts Technician, Other , West Chester, Ohio

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