Position Summary:

To support the manufacture of Commercial Gliadel wafers, including execution of approved SOPs and batch records to produce a quality product according to GMP guidelines. Takes responsibility for manufacturing a quality product, performs equipment cleaning and maintenance per approved procedures, reviews and edits documentation, and supports protocol execution and equipment maintenance.

Duties & Responsibilities:

Manufactures product according to SOPs and Batch Record instructions and takes responsibility for manufacturing a quality product.
Performs set-up, dismantling and maintenance of equipment and assures equipment is ready for production operations.
Completes cleaning, autoclaving & depyrogenating of equipment.
Weighs chemicals accurately.
Performs integrity tests on filters.
Participates in all processes of manufacturing.
Prepares solutions for sanitizing & performs routine sanitization of areas.
Conducts manufacturing activities to protect themselves, others, and company assets.
Complies with SOPs, Batch Records, and other GMP documentation.
Reviews work of self and others to ensure accuracy and compliance with good documentation practices.
Participates in on-going training.
Reports any compliance issues to Manufacturing Manager.
Assists in training new and existing employees
Reviews and edits SOPs, batch records, and other documentation.
Completes & reviews batch records ensuring the accuracy of the document prior to review by management
Ensures that routine audits are completed accurately and in a timely manner
Edits qualification protocols for new and/or existing equipment or systems
Requests Production Batch Records from QA at least one week prior to scheduled production
Performs equipment maintenance such as periodic equipment cleaning, inspection, and filter changes, ect.
Trouble shoots equipment as necessary during production operations.
Completes annual GMP & safety training.
Continues SOP training as it pertains to daily tasks & participates in on the job training.
Develops new skills and knowledge which are beneficial to self and Guilford
Cross trains to support other departments
Identifies process opportunities and offers suggestions.
Participates in trending of processes and/or processing parameters and provide initial evaluation of the data – notifying Manufacturing Manager of trends.
Participates in execution of protocols & experiments to resolve issues and find solutions.
Maintains inventory of equipment and supplies and ensures the availability for production activities.
Recommends scheduling or other efficiency improvements as indicated.

Minimum Requirements:

2-4-year college education in a scientific discipline
2 years minimum work experience in a GMP environment

Desired:

Experience with GMP commercial product manufacturing of pharmaceutical products
Prior Cleanroom experience preferred
Knowledge of US and EU GMP regulations

NOTE: This job description is not intended to be all-inclusive. Associate may perform other related duties to meet the ongoing needs of the organization.

An Equal Opportunity Employer

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