Production Operator - Osmotica Pharmaceuticals

Alora Pharmaceuticals, LLC.; Marietta (GA); On-site; USD 42,000 - 64,000; Full time

Job summary

Alora Pharmaceuticals, LLC is seeking an experienced production operator to operate special purpose machines in oral solid dose manufacturing. You will set up and run granulators, blenders, mills, tablet presses, coaters and packaging lines to specification on production batches.

The role requires following Master Batch Records, SOPs and validation protocols, completing logs accurately, maintaining clean equipment, weighing materials for batches, and collaborating with Analytical Sciences and QA

Qualifications

• Ability to read and comprehend SOPs, Batch Records and training documents.
• Experience in GMP/FDA regulated manufacturing or similar facilities.
• Able to stand 8 hours and lift up to 50 pounds.

Responsibilities

• Set up and operate granulators, blenders, mills, tablet presses, coaters and packaging equipment.
• Follow Master Batch Records, SOPs and validation protocols.
• Accurately complete equipment logs and lab notebooks.
• Maintain cleanliness and proper assembly of manufacturing equipment per SOPs.
• Weigh materials for production batches.
• Interface with Analytical Sciences and Quality Assurance personnel.
• Adhere to all cGMP and FDA regulations.
• Perform other duties as assigned.

Skills

Communication

SOP literacy

Multi-tasking

Interpersonal skills

Education

High School Diploma

Technical certificate

Job description

Description

Operators are responsible for operating special purpose machines or industrial equipment to specifications on production basis in typical oral solid dose pharmaceutical manufacturing. Processes include dispensing and weighing of materials, using automatic and semi-automatic equipment for tablet manufacturing, combining materials to make blends and solutions, and packaging of finished product.

Essential Responsibilities

• Ensure the proper set-up and operation of standard pharmaceutical process equipment such as Granulators, Blenders, Mills, Table Presses, Tablet Coaters and Packaging.
• Ensures proper execution of Master Batch Records, standard operating procedures and validation protocols.
• Ensures accurate completion of equipment logs and/or lab notebooks.
• Ensures cleanliness and proper assembly of manufacturing equipment per approved procedures (SOP’s).
• Weighs out material and components for production batches.
• Interfaces and consults with Analytical Sciences and Quality Assurance personnel.
• Understands and adheres to all cGMP and FDA regulations.
• Performs other duties as assigned or requested

Core Competencies

• Excellent written and verbal communication skills.
• Ability to read and comprehend SOP’s, Batch Records and training documents.
• Ability to multi-task effectively
• Excellent interpersonal skills and ability to effectively interact with different functional groups.

Minimum Qualifications

• High School Diploma or equivalent or technical school certificate
• 1-3 years solid dose production operator experience or previous experience working in a regulated manufacturing environment (GMP or FDA), such as food and chemical processing facilities.

Physical Requirements

• Must be able to stand for an 8 hour shift and lift, push or pull up to 50 pounds.
• Ability to wear any type of protective equipment

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.