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MO-SSM Health St. Clare Hospital - Fenton

Worker Type:

Regular

Job Summary:

The 503B Production Technician is responsible to prepare and admix sterile pharmaceutical products in a highly controlled, regulated environment. This Technician will undergo stringent training program to become qualified to work in aseptic environment inside ISO 7 rooms and ISO 5 workspaces ensuring admixtures are completed properly per FDA and cGMP requirements. The 503B Production Technician is also responsible for managing product inventory and supplies and is expected to maintain a highly organized clean room. This Technician will work with the team to ensure compliance to standard operating procedures and regulatory requirements.

Job Responsibilities and Requirements:

PRIMARY RESPONSIBILITIES

• Prepare IV as admixtures for batch compounding of routine items.
• Performs general cleaning and maintenance duties as directed.
• Participates in cleanroom product preparation prior to sterile filling.
• Verify materials for use in batch compounding
• Label, package, and document per written instructions
• Package product in IV Bags, cartons, syringes, vials, overwraps.
• Replenish packaging materials to areas/work cells as directed
• Complete end of batch reconciliation and count verification
• Retrieve product samples
• Maintains manufacturing records and completes all required documentation in compliance with cGMP, FDA, USP and pharmacy state board regulatory guidelines.
• Operate and monitor technical, computerized compounding / filling equipment ensuring quality standards are maintained.
• Assists with other duties as required.

EDUCATION

• High school diploma or equivalent

EXPERIENCE

• Active MO State Pharmacy Technician Registration with State or National certification preferred
• Minimum 2 years of prior Sterile Compounding Experience preferred
• Knowledge of IV products and compounding procedures preferred
• General knowledge of proper cGMP aseptic gowning procedure and technique preferred
• Familiarity with, and the ability to follow established Standard Operating Procedures (SOP), Master Batch Records, and adhere to cGMP
• General knowledge of USP 797 and/or cGMP aseptic processing
• Strong attention to detail, good math skills, and knowledge of Metric System
• Must be able to spend a majority of time standing
• Must be able to work well both individually and on a team
• Must be able to lift, push, pull and carry up to 40+ pounds
• Must be able to operate in full gowning protocol without skin exposure

PHYSICAL REQUIREMENTS

• Frequent lifting/carrying and pushing/pulling objects weighing 0-25 lbs.
• Frequent sitting, standing, walking, reaching and repetitive foot/leg and hand/arm movements.
• Frequent use of vision and depth perception for distances near (20 inches or less) and far (20 feet or more) and to identify and distinguish colors.
• Frequent use of hearing and speech to share information through oral communication. Ability to hear alarms, malfunctioning machinery, etc.
• Frequent keyboard use/data entry.
• Occasional bending, stooping, kneeling, squatting, twisting and gripping.
• Occasional lifting/carrying and pushing/pulling objects weighing 25-50 lbs.
• Rare climbing.

Certified Pharmacy Technician (CPhT) - National Healthcareer Association (NHA), Certified Pharmacy Technician (CPhT) - Pharmacy Technician Certification Board (PTCB), FUTURE - Certified Pharmacy Technician (CPhT) within 24 months - National Healthcareer Association (NHA), FUTURE - Certified Pharmacy Technician (CPhT) within 24 months - Pharmacy Technician Certification Board (PTCB), FUTURE - Pharmacy Technician, Registered within 2 months - Illinois Department of Financial and Professional Regulation (IDFPR), FUTURE - Pharmacy Technician, Registered within 6 months - Missouri Division of Professional Registration, FUTURE - Technician within 3 months - Oklahoma State Board of Pharmacy, MO Registration Application and Finger Print Process Complete AT TIME OF HIRE - Missouri Division of Professional Registration, Pharmacy Technician, Registered - Illinois Department of Financial and Professional Regulation (IDFPR), Pharmacy Technician - Missouri Division of Professional Registration, Technician - Oklahoma State Board of Pharmacy

Work Shift:

Day Shift (United States of America)

Employee

Department:

3923000113 SC-SL RX Outsourcing

Scheduled Weekly Hours:

40

SSM Health is an equal opportunity employer. SSM Health does not discriminate on the basis of race, color, religion, national origin, age, disability, sex, sexual orientation, gender identity, pregnancy, veteran status, or any other characteristic protected by applicable law. Click here to learn more.