Formulation Technician I

Job Description

Job Description

FORMULATION TECHNICIAN I

Location : Denver, CO

Department : Production

FLSA Status : Non-Exempt

GENERAL DESCRIPTION :

This position reports directly to the Manufacturing Supervisor. The Formulation Technician is responsible for the setup, preparation, and formulation of bulk sterile drug product(s) including the completion of associated documentation within the Aseptic Formulation Area.

ESSENTIAL FUNCTIONS :

This description is intended to be illustrative of the major duties performed by the employee assigned to this position.

Follow SOPs, product batch record instructions, and corresponding quality documentation.

Set up and operate formulation, decontamination, and sterilization equipment such as heating stir plates, scales / balances, pH meters, biosafety cabinets, isolators, autoclaves, and depyrogenation ovens.

Prepare and maintain accurate documentation following cGMP and GDP principles.

Ensure proper accountability and traceability of components, ingredients, and finished products.

Report and make recommendations regarding equipment, facilities, supplies, required repairs, process concerns, safety concerns, and areas for improvement in quality, yield, and efficiency.

Recognize process errors and / or equipment malfunctions and notify supervision accordingly.

Utilize and handle appropriate supplies and raw materials with proper aseptic manufacturing techniques.

Support equipment calibration, equipment / utility validation, and preventive maintenance as needed.

Clean and disinfect cleanrooms, equipment, and supplies in support of routine production.

Training of team members following certification, as needed.

Adhere to facility safety policies and procedures and proactively identify unsafe conditions.

Other duties as assigned.

Experience & Necessary Skills :

• 1-year previous experience or comparable experience preferred.
• Minimum 1 years’ experience in aseptic processing preferred.
• Knowledge of cGMP guidelines / standards.
• Demonstrated written and oral communications skills including strong presentation skills.
• Excellent organizational skills.
• Strong results orientation.
• Microsoft Office skills, including use of spreadsheets and word processing programs.
• Must pass English Competency Test
• Proficient written, verbal and oral English communication skills.
• Medical manufacturing experience
• Assembly line” production experience
• Ability to stand for long hours doing repetitive tasks with precision
• Someone who can put integrity and quality at the forefront of their work
• Someone who is looking to make Leiters their long-term position
• Someone with a track record of employment longevity
• When scheduling interviews- please be sure to communicate

Pay Rate $20.00-$24.00 DOE

Pay Details : $20.00 to $24.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer / Veterans / Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and / or security clearance requirements, including, as applicable :

Massachusetts Candidates Only : It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.