Hikma Pharmaceuticals Dayton , NJ 08810
Posted 2 weeks ago
JOB PURPOSE
Perform functions within the Microbiology Laboratory related to Environmental Monitoring of controlled production areas. The duties also include equipment maintenance and LIMS management.
KEY ACCOUNTABILITIES
Perform routine daily, weekly, and monthly environmental monitoring for controlled areas (ISO5, ISO7, and ISO8).
Prepare personnel and room plates daily.
Perform personnel and room batch level environmental monitoring sampling.
Perform daily cleanroom exit monitoring sampling.
Request and drop off RODAC and TSA environmental monitoring plates required for compounding department on daily basis.
Perform controlled area recovery sampling following shutdown activities through a DCE request.
Perform gowning qualification and re-qualification sampling for cleanroom personnel.
Regular and predictable onsite attendance and punctuality.
Ensure Environmental Monitoring (EM) of the facility's controlled areas is performed as required.
Document EM testing into the EM database prior to incubation, ensure samples are correctly incubated, and record sample results in the EM database following incubation.
Compile trending data for EM testing to support investigations.
Audit personnel aseptic technique in controlled areas including during process simulations (media fills).
Author laboratory event and investigation reports.
Communicate issues between departments as appropriate.
Communicate effectively with co-workers to ensure all required tasks are completed as expected.
Document test data clearly and accurately. Maintain data integrity and ensure compliance with company policies, procedures, cGMPs, and regulatory requirements.
QUALIFICATIONS
Minimum:
0-2 years pharmaceutical microbiology or environmental monitoring experience
Must be able to pass and maintain Class 100/ISO 5/Grade A gowning qualification.
EXPERIENCE & SKILLS
Must be able to lift 20 lbs.
Ability to handle multiple tasks concurrently and complete tasks in a timely fashion
Computer literate
Must be able to communicate effectively across all departments and levels of management
Understanding of laboratory instruments and methods
Must have excellent writing skills to write clear and concise reports.
Knowledge of pharmaceutical microbiological methods and cGMPS as well as an understanding of scientific principles preferred.
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