Title: Lead, Formulation and Fill Technician

Job Summary

Performs the formulation and dispensing of pharmaceutical products according to current Good Manufacturing Practices (cGMPs) and utilizing Standard Operating Procedures (SOPs) in a clean room environment. Able to fill in for Supervisor and take on a leadership role when not available.

Area of Responsibility

• Formulate and dispense product in a clean room environment for Radio-pharm as well as dermatological products
• Wash and sterilize all equipment, tubing, filters, stoppers, vessels, vials, ampoules etc.
• Perform all automatic and manual manufacturing processes as needed
• Establish and perform routine checks of all in-process testing for Radio-pharm as well as dermatological products
• Perform all required cleaning of manufacturing facility and equipment as needed
• Follow all company policies relating to job safety
• Work under direct supervision and follow clearly described procedures
• Perform preparation and set-up of glassware and lab equipment to ensure proper conditions for production process
• Document data and review completed batch records to ensure product is made in accordance with specifications
• Solve moderate to complex problems related to the product, process and transfer of new and existing products
• Assist in Batch Record and SOP review, updating through DCR’s as needed
• Draft and track CAPA’s, deviations and DCRs as required
• Perform equipment monitoring and maintenance under direction, as needed
• Complete all necessary paperwork to conform with FDA regulations
• Oversee inventory control in the production area, order supplies as needed and assists in the management
• Other duties as assigned

Work Conditions:

• Office
• Lab
• Controlled areas

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach or push with hands and arms
• Stoop, kneel, crouch or crawl
• Talk or hear
• Close vision, color vision, peripheral vision, depth perception, ability to focus
• Ability to visually inspect small products and print
• Operate lab equipment
• Operate computers/office machines
• Must wear lab coat and other safety attire
• Lift up to 50 lbs

Education and Job Qualification

• High School Diploma required; B.S. in related field preferred or equivalent experience
• Education in Life sciences or technical discipline
• Formal cGMP training is required
• Good organizational and record keeping skills
• Good computer skills
• Attention to detail required to plan, prioritize and organize diversified workload
• Strong verbal, written and interpersonal communication skills
• Basic math and record keeping skills
• Flexibility to work on either first shift or second shift if coverage is needed in Supervisor’s absence

Experience

• Minimum 6 years or more related experience
• Experience with aseptic fill/finish, formulation techniques
• Component prep experience
• Experience working in a controlled environment
• Related experience in pharmaceutical environment

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.