A Manufacturing Technician I is responsible for the manufacturing of tablets and capsules for commercial distribution and clinical trials. Personnel in this position will operate manufacturing processing equipment by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices.
Key Job Responsibilities:
Follow written procedures.
Provide assistance to other operators.
Document activities clearly and accurately.
Perform basic math calculations.
Operate solid oral dosage manufacturing equipment.
Operate material handling equipment.
Perform in-process testing.
Perform cleaning of rooms, tools and equipment.
Essential Job Requirements:
High School Diploma or equivalent.
0 to 2+ years. Mechanical or pharmaceutical experience not required. Mechanical aptitude or work within a regulated environment preferred.
Safety - Ability to wear Personal Protective Equipment (including gowning and powered respirators). Understands and follows safety procedures and works in a manner to avoid injury to self and co-workers. Willingness to work with highly toxic and controlled materials.
Quality Control – Ability to conduct routine in-process testing and visual inspections and identify out-of-specification conditions.
Regulatory Compliance – Ability to work in a regulated environment (FDA / DEA / OSHA) and strictly follow procedures.
Communication – Effectively communicates both verbally and in writing. Ability to read and comprehend detailed written instructions.
Documentation – Ability to clearly and concisely document all work activities in a timely manner utilizing existing forms and records. Writes legibly.
Data Handling – Perform basic math functions to include product accountability and material adjustment calculations and rounding. Basic computer skills.
Material Handling – Ability to move materials throughout facility using appropriate methods and equipment.
Equipment Operation – Operate machinery and read process control instruments to ensure proper operation. Identify operational problems when they occur.
Cleaning – Ability to clean rooms, equipment and tools for use in a cGMP environment.
Maintenance – Perform basic troubleshooting applications.
Training – Provide basic training to other operators after learning a skill set. Trainer certification not required.
Client Interaction – Minimal interaction. On an as needed basis.
Leadership – Exhibited leadership skills in individual areas of expertise.
Work Schedule – Must have the ability to work overtime when required.
May directly interact with auditors during scheduled inspections.
Teamwork – Ability to work effectively within a team environment.
Certifications: None required.
Supervision Received: Direct
Relies on experience and judgment to plan and accomplish goals within defined procedures and practices. Seeks management direction for problems of diverse scope.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds and occasionally lift and/or move over 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts; fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to: safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.
LIMITATIONS AND DISCLAIMER
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position.
All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.
This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.