Job Description

Company: TPPTECH CDMO

Job Description for: Aseptic Compounding Technician

Position Summary:

Aseptic Compounding Technician prepares compounded sterile products and performs related activities under the direction of a qualified individual with sterile operations experience.

Responsibilities: Essential Duties

• Adheres to all company policies and procedures
• Prepares compounded sterile products using aseptic technique.
• Assists in the setup of the compounding room, equipment, and supplies for preparation of compounded sterile solutions, using aseptic technique.
• Performs general cleaning and maintenance duties as directed.
• Participates in cleanroom product introduction activities.
• Prepares records and monitors results for pharmaceutical quality assurance testing.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

General: It shall be the duty of every employee while at work to take reasonable care for the safety and health of himself/herself and other persons.

Expertise: Knowledge & Skills

• Requires working knowledge of technical field/area of specialization.
• Exercises general application of principles, theories and concepts.
• Follows established procedures and guidelines.
• Works under direct supervision and from detailed verbal and/or written instructions.
• Uses established procedures to accomplish assigned task.
• May require some limited judgement in resolving problems.
• Contacts are primarily with direct supervisor, peers and subordinates.
• Sterile Compounding experience is required at a minimum of 2 years.

Expertise: Qualifications -Education/Experience/Training

Required:

• High school diploma/G.E.D or equivalent required.
• 0-2 years of related experience required.
• Applicable industry/professional certification required.
• Regular and predictable on-site attendance
• cGMP training/experience desired, training will be provided
• Aseptic processing training/experience desired; training will be provided.
• Active State of California Pharmacy Technician License
• Schedule: Minimum 40-hour work week (5x8 and 4x10), 8-10-hour shifts. Work 4-5 days per week between Monday - Sunday w/ alternating weekends. Holidays/Overtime as needed.

While performing the duties of this job, the employee is regularly required to sit, talk, or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

While performing the duties of this job, the employee is expected to:

• Moderate work – Exerting up to 40 lbs of force occasionally, and/or up to 20 lbs of force frequently, and/or 10 lbs force constantly to move objects.
• Lifting, Carrying, Pushing, Pulling and Reaching:
• Occasionally Sit
• Frequently: Reaching upward and downward, push/pull
• Constantly: Stand, Visual Acuity with or without corrective lenses

Activities:

• Occasionally: Sitting, Walking
• Frequently: Finger feeling, Handling, Push/pull, reaching upward and downward, Talking - ordinary, loud/quick
• Constantly: Hearing - ordinary, fine distinction, loud (hearing protection required), Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing

Environmental Conditions:

Occasionally: Proximity to moving parts, Exposure to toxic or caustic chemicals (in most areas)

Work Environment:

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.

• Noise Intensity: Moderate
• Occasionally: Office environment
• Frequently: Production/manufacturing environment, Lab environment
• Constantly N/A

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