Clinical-Scientific - Bioanalyst

Company: Pioneer Data Systems
Location: Rocky Mount
Posted on: March 18, 2023

Job Description:

Position Details:
Our client, a world-leading Pharmaceutical Company in Rocky Mount, NC is currently looking for a Microbiologist / Endotoxin Testing to join their expanding team.

Job Title: Microbiologist / Endotoxin Testing / Pharma Manufacturing
Duration: 18 months contract, extendable up to 36 months
Location: Rocky Mount, NC

Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan

Job Description:
Manager is looking for at least 2+ yrs full time experience with microbiology lab/environmental monitoring exp plus testing methods!

URGENT NEED

These individuals will perform a variety of assays supporting validation efforts for the new R3 facility. Including but not limited to endotoxin (gel clot and kinetic method), sub-visible particulate, media fill reads.
Proper GMP documentation guidelines will be adhered to as well as Pharmaceutical standards and requirements.
Strong communication skills and the ability to work cross functionally across engineering, manufacturing, and quality is required.

Expectations:
Complete and stay on top of PLS training
Be able to work independently on assigned assay and sample load
Coordinate and work effectively with other groups at the site
Communicate project status to management
First time quality mentality
Team player and enthusiasm for the work

Most of the time will be spent in the lab.
Will work independently on their assigned sample load, and interact with management and validation as needed for the project.
Some desk work will be required for writing up reports and revising protocols, entering in results into LIMS, etc.

Monday to Friday 1st shift day schedule, 40 hours minimum/week, OT and off hours might be required depending on cycle of work and manufacturing runs, not consistent but will need to be flexible depending on business need. Shift schedule could vary, some weekend work.

Notes:
Emphasis on FTE work experience about 2+ yrs
Raw material testing, utility sampling, stability testing, and method
Environmental Monitoring exposure --
1. ENDOTOXIN (gel clot, kinetic method)
2. LIMS, SOPs, validation/testing methods,
Manufacturing environment

Experience MUST be at least 2+ yrs as full time work!!

Hard Skills:
Pharmaceutical manufacturing quality control microbiology Bacterial Endotoxin Testing (BET) Kinetic and/or Gel-Clot method, Sterility, Particulate (HIAC) testing
cGMP
cGDP
BS (4 year degree) in Biology or relative science(s)

We are looking for someone with pharmaceutical experience, has a background/education (BS) in Biology and/or other relative sciences, has worked in finished product laboratories before (BET, Sterility, Particulate, Assay, etc.), quick learner and works well individually and on a team

Comments:
100% onsite will need to adhere to return to site policy
Duration: 18-Months

Requirements:
Bachelors degree in Microbiology, Biology, or related life science field
Minimum 2+ years of experience as a microbiologist in a pharmaceutical manufacturing setting
Experience with one or more of the following QC tests: endotoxin, sub-visible, and sterility
Understands GMP documentation
Prior experience with technical writing of SOP's or reports is a plus

Keywords: Pioneer Data Systems, Rocky Mount , Clinical-Scientific - Bioanalyst, Healthcare , Rocky Mount, North Carolina