These critical Team Members prepare and admix sterile pharmaceutical products in a highly controlled, regulated environment. This Team Member 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.
BE ADVISED THIS IS A 2ND SHIFT POSITION: 2PM - 11PM
- Undergo thorough training curriculum on gowning, compounding, aseptic manipulations, USP 797 regulations, FDA cGMP-503B regulations, media fills, internal SOP's.
- Ability to appropriately don sterile frock aseptically
- Prepare materials to be entered into compounding areas.
- Garb up using fully sterile gowning attire
- Prepare IV as admixtures for batch compounding of routine items.
- Typical admixtures prepared at this facility include IV Bags, syringes, and specialty container closures.
- Document work performed at multiple stages in the process.
- Participate and assist with line clearance activities
- Continuous improvement, safety, and training
- Identify, communicate and solve problems to ensure quality, efficiency, and safety objectives are met
Other duties could include at times:
- Count materials/product to ensure accurate count
- Apply labels to various components
- Replenish packaging materials to areas/work cells as directed by Group Leader.
- Assist with Inventory
- Verify incoming materials for use
- Perform bar code and systems challenges (as applicable) for equipment used
- Complete end of batch reconciliation and count verification
- Retrieve product samples
- Monitor and ensure appropriate downtime and efficiency information is logged accurately
Successful Candidates Will Have:
- Strong, consistent attention to detail.
- Ability to focus and have high level of attention to detail for extended period, even at fast pace.
- 1 year previous Pharmaceutical Manufacturing or Pharmacy Technician experience preferred, but not required.
- Computer proficiency in Microsoft Word, and Outlook and the ability to use enterprise software
- Must have a strong understanding of professionalism and responsibility to have the chance to prepare these sterile medications.
- This job has no supervisory responsibilities.
- This position operates in an aseptic cleanroom environment and wear complete PPE at all times
- Standing for long hours in PPE. At times over 7 hours per day and sitting up to 4 hours at a time.
- Lift, push/pull and carry up to 35 lbs
- Use of hands/fingers to manipulate equipment is required.
- 1 year previous experience in pharmaceutical environment
SCA Pharmaceuticals is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.