Using company procedures and guidelines, the Aseptic Compounding Technician I is responsible for preparing compounded sterile preparations according to batch record instructions. This shall include setting up and operating all compounding equipment, filling of medical device containers, equipment cleaning, and documentation of all related activities.
- Regular and predictable onsite attendance and punctuality
- Accurately and aseptically prepare compounded sterile preparations according to batch record instructions and per internal SOPs and cGMPs to ensure the quality and integrity of products
- Demonstrate appropriate cleanroom behavior and aseptic technique
- Set up and operate all compounding equipment safely and accurately according to policy and procedure
- Complete and maintain applicable logbook and batch record paperwork abiding by Good Documentation Practices (GDPs)
- Execute aseptic qualification and equipment qualification protocols as required
- Maintain aseptic qualification and gown qualification
- Collect environmental monitoring samples and perform other quality checks as necessary
- Escalate any and all process issues to the area supervisor or designee
- Perform thorough cleaning and disinfection of the Clean Room areas per internal SOPs
- Maintain good hygiene prior to coming into work each day
- Perform other related duties as determined by management personnel
- High School Diploma or equivalent required,
- College degree (BA/BS) in Biological Sciences, Microbiology, or other related science field; PTCB CPhT certification or equivalent, PTCB CSPT certification or equivalent preferred.
- Two (2) years of cGMP pharmaceutical manufacturing experience required.
- Cleanroom experience with training on aseptic technique; IV bag and/or syringe compounding experience is preferred.
- Good oral and written communication skills are essential
- Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs
- Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form
- Must be able to read and understand complex compounding/formulation and filling procedures
- Ability to examine problem areas and make recommendations for corrective action
- Must be able to comprehend and follow all applicable SOPs
- Heavy continuous exertion
- Will be required to lift 5 – 40 pounds
- Must be able to stand for long periods of time
- Must be able to wear required PPE
- Work involves exposure to drug substances which may require special handling and protective equipment
- Must work in a cleanroom environment wearing company-issued scrubs, as well as a hood, coverall, boots, gloves, and goggles
- The noise level is moderate to loud in the cleanroom areas
- The use of sanitizing agents to clean the cleanroom areas may be moderately
What We Offer
- Clean climate-controlled working environment
- Annual performance bonus potential
- 401k employer match up to 6% of your contributions
- 23 vacation/personal days
- 11 paid Company holidays
- Generous healthcare benefits
- Employee discount program
- Wellbeing rewards programs
- Safety and Quality is a top organizational priority
- Career advancement/growth opportunities
- Tuition Reimbursement
- Maternity and Parental Leave
- Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms
