Temp to Perm – Maryland
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.
• 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. Performs routine sanitization of areas.
• Completes cleaning, autoclaving & depyrogenating of equipment.
• Performs equipment maintenance such as periodic equipment cleaning, inspection, and filter changes, etc.
• Trouble shoots equipment as necessary during production operations.
• Maintains inventory of equipment and supplies and ensures the availability for production activities.
GMP Compliance / Documentation Management (10%)
Complies with SOPs, Batch Records, and other GMP documentation.
Reviews work of self and others to ensure accuracy and compliance with good documentation practices.
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
Edits qualification protocols for new and/or existing equipment or systems
Participates in trending of processes and/or processing parameters and provide initial evaluation of the data – notifying Manufacturing Manager of trends.
Training/Personal Development/Process Improvement (10%)
Recommends scheduling or other efficiency improvements as indicated.
Conducts manufacturing activities to protect themselves, others, and company assets.
Participates in on-going training.
Completes annual GMP & safety training.
Cross trains to support other departments
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 Eisai
Identifies process opportunities and offers suggestions.
2-4-year college education in a scientific discipline (or comparable experience)
2 years minimum work experience in a GMP environment
Other Desired Skills/Abilities
• Experience with GMP commercial product manufacturing of pharmaceutical products
• Prior Cleanroom (and gowning) experience preferred
Knowledge of US and EU GMP regulations
Proactive work habits.
Must be able to sit for extended periods of time.
Ability to lift/transport up to 50 pounds.
Company offers very competitive hourly rate for contract role. FT salary is $40k plus 6-8% bonus