Job Description

JOB SUMMARY

The Sterile Compounding Pharmacy Technician shall be responsible for accurately mixing, preparing, and producing Compounded Sterile Products (CSP) in accordance with cGMP, USP <797> , and USP <800> , maintaining the sterile compounding area (cleanroom) integrity, and following all Company SOPs under the direct supervision of a pharmacist. The Sterile Compounding Technician will assist in all aspects of pre-production, cleanroom, and post-production of CSPs, including documentation of batch records. The Sterile Compounding Technician will assist the pharmacist(s) to ensure adherence to Apertus Compounding’s (APC's) SOP’s and policies, adherence/compliance to state and federal regulations and with the production of APC’s products. The Sterile Compounding Technician will perform the daily operational pharmacy duties to ensure that timely, compliant, and high-quality production is met each day. The Sterile Compounding Technician will work with the PIC to help develop and maintain departmental training in accordance to the company’s policies and procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following but not limited to:

· Perform technical and aseptic manipulations in the ISO 5 laminar hoods.

· Compounds all required types of sterile preparations accurately and in compliance with the batch record, as well as cGMP, USP <797> , and USP <800> .

· Perform sterile techniques such as injecting active drug into sterile IV bags, filling syringes with medication for injection, pooling vials into sterile empty bags with repeater pump and mixing (APIs) active pharmaceutical ingredients into finished drug product.

· Maintain a culture of safety and quality by immediately notifying a pharmacist of any observed deviations, errors, or procedural concerns during the compounding process.

· Proper documentation, labeling and packaging of orders & finished products, including documentation of batch records, lot numbers, and expiration dates, using good documentation practices, ensuring drugs & supplies are in data before use.

· Demonstrates thorough knowledge of the job, completing all annual competencies and skills validations.

· Keep training records updated and current.

· Work with pharmacists to ensure production schedules are tracked and met. Help monitor for Daily Improvement (MDI) boards used to track production and compliance, and collaborate with PIC to meet continuous improvement initiatives.

· Understanding of the importance/impact of cGMP standards and stay current with updated versions of cGMP. Ensures Good Documentation Process (cGDP) within the department.

· Ensure compliance with regulatory requirements following local, state, and federal laws regarding the profession of pharmacy practice.

· Accurate and timely completion of all required documents, forms, and reports as outlined in the Company’s SOP’s and policy, and procedure manual.

· Develop and implement new products, SOP’s overview, and training records.

· Overseeing the maintenance of all departmental production areas as clean, safe, and secure.

· Ensures all equipment are in good working condition and well maintained on a daily basis, in accordance with company SOPs and all applicable state & federal regulations.

· Operates all compounding equipment accurately.

· Plan and participate in the product validation process, media fills, and clean room certification processes.

· Completes any other duties designated by the pharmacist and/or supervisor that may be assigned from time to time, or common for your position.

· Cooperate with team members to accomplish departmental goals.

· Help with team meetings/ huddles.

MINIMUM REQUIREMENTS NEEDED TO APPLY

· Legally authorized to work in the job posting country.

· Licensed as a Pharmacy Technician in Missouri and/or (CPhT) required

· ACPE Sterile products certification

· IV compounding experience a must.

· High School diploma or general education degree (GED) required

· Knowledge of cGMP regulations as it pertains to 21 CFR 210, 21 CFR 211

· Strong understanding of USP <795> , USP <797> , and USP <800>

· Able to work a full shift with bunny suit garb and goggles in a sterile environment.

· Able to work weekends and overtime (as required).

· Excellent attention to detail, organization, and communication skills.

EXPERIENCE

· Active pharmacy technician license issued by the Missouri Board of Pharmacy, that is in good standing.

· Have at minimum two (2) years of aseptic sterile compounding experience.

LANGUAGE SKILLS

· Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

REASONING ABILITY

· Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

PHYSICAL DEMANDS

• Must frequently lift and/up move up to 25 pounds

• Be able to stand for multiple hours throughout the day.

• Must be able to garb and gown in a bunny suit and goggles.

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to sit; stand; walk; use hands to handle or feel; and talk or hear. The employee frequently is required to reach with hands and arms.

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