Hikma Pharmaceuticals Dayton , NJ 08810
Posted 2 months ago
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
Location:
Dayton, NJ, US, 08810
Nearest Major Market: New Jersey
Hikma Pharmaceuticals