Manufacturing Technician

Job Title: Manufacturing Technician

Position Type: Full Time

Location: Clearwater, FL

Travel Required: < 5%

Reports to: Manufacturing Supervisor

Company Overview

QOL Medical is a privately owned, patient-centric company founded in 2003 to focus on the acquisition and commercialization of orphan products in underserved markets, particularly in the field of gastroenterology. QOL Medical ensures an expanded clinical awareness and patient access for improved quality of life in the treatment of rare and orphan diseases. The Company currently markets two FDA-approved products: Sucraid (sacrosidase) Oral Solution and Ethamolin (Ethanolamine Oleate) Injection, 5%.

Summary

The Manufacturing Technician is responsible for overseeing manufacturing and maintaining a state of production readiness among the manufacturing cleanroom suite. He/She will ensure that all projects and commercial manufacturing are executed in a compliant and efficient manner. He/She will aid in managing and maintaining all consumables associated with API manufacturing within QOL facilities.

Role and Responsibilities

• Work directly with management and personnel to complete assigned duties and support manufacturing.
• Attend applicable meetings, discussions, etc., in support of these projects.
• Support department preparations for regulatory inspections by associated agencies such as FDA, MHRA, EMA, etc.
• Execute Batch Records, Protocols, Qualification Documents, and Quality Records in a compliant and efficient manner.
• Ensure all executed documentation is completed in their entirety.
• Ensure all applicable equipment is calibrated and maintained within specified projects.
• Write and review Standard Operating Procedures (SOPs), and other procedures as required.
• Participate in safety processes and meetings as applicable.

Qualifications and Education Requirements

• 4-year undergraduate engineering degree or equivalent experience.
• Experience in statistical analysis.
• Proven problem-solving skills in a dynamic manufacturing environment.
• Strong written and verbal communication skills.
• Strong organizational and time management skills.
• Experience with standard software packages such as Microsoft Word, Excel, Access, PowerPoint, Adobe Acrobat, office scheduling software such as Microsoft Outlook, E-mail, and internet web.

Work Environment

This position is a manual manufacturing process, utilizing up to 13-hour shifts on a fixed schedule. While performing the duties of this job, the employee may be exposed to fumes or airborne particles, moving mechanical parts, and vibration. The employee may also be occasionally exposed to a variety of extreme conditions at manufacturing job sites. The noise level in the environment and manufacturing facility can be loud. This position works in a cleanroom environment in which safety, environmental, and health concerns may demand constant attention.

Physical Demands

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. While performing the duties of this job, the employee is regularly required to read, count, and write to accurately complete all documentation. The employee is frequently required to stand, walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to sit; climb, or balance; and stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Must be able to operate and use all necessary equipment. Must be able to climb ladders and move items that can weigh up to 50 pounds.

This job description reflects the general duties and responsibilities necessary to describe the essential functions of the job, as identified, and shall not be considered an exhaustive list of job duties and responsibilities which may be inherent in the job. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The duties requirements listed are representative of the knowledge, skill, and/or ability required. The duties and responsibilities listed may be subject to change by the company at any time, and an employee may be asked to perform duties outside of his or her regular duties and responsibilities to support the ongoing operations of the company.

Expected Hours and Position Type

This is a full-time position which typically involves 40 hours a week. On occasion, the employee may need to respond during early/late hours to resolve unforeseen issues arising from the need of manufacturing projects. This position functions in a team-oriented environment requiring constant interactions with an assigned team, where expectations are equal across the team performing the assigned tasks.

Employee Acknowledgement

I have received a copy of the foregoing job description, and I understand the requirements of the position.

Job Type: Full-time

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Compensation Package:

• Bonus opportunities

Schedule:

• 12 hour shift
• 8 hour shift
• Day shift
• Monday to Friday
• Overtime

Education:

• High school or equivalent (Preferred)

Experience:

• Manufacturing: 1 year (Required)

Shift availability:

• Day Shift (Required)

Work Location: In person