Quality Laboratory Person in Plant (QPIP)

Location: Baltimore, MD
Department: Azzur Washington DC, LLC

Job Description

We at Azzur Group are looking for an experienced Quality Laboratory Person in Plant (QPIP) to join our team. 

Key Responsibilities
a. Oversees testing in the Quality Control laboratories while strictly ensuring adherence to site work instructions, Federal Regulations, cGMP and site policies and procedures.
b. This position requires the individual to oversee routine testing as scheduled to support production and reviewing required documentation.
c. Knowledge of general Microbiological and analytical techniques including aseptic processing, and culturing of both bacterial and viral isolates.
d. Experience with tissue culture, microbial enumeration and preparation of dilutions is preferred.
e. Familiarity of functions within the following systems is required: SAP, Trackwise, LIMS, Documentum, etc.
f. Assists with maintaining safety and compliance of the laboratory work area.
g. Performs cleaning of laboratories, equipment, and ancillary areas as required.
h. Understand and support change controls, CAPAs, and deviations in the QA system.
i. Develop a working knowledge of appropriate compendia and/or regulatory guidance.
j. This position will be filled as an on-shift and off-shift position, which includes second shift and/or weekends.

Required Experience/Knowledge
a. BS/Microbiology/Biological Sciences with relevant work experience required with 5 years of experience.
b. Excellent knowledge both hands on and theoretical knowledge of routine testing in a Biologics/Vaccine environment including aseptic processing, tissue culture, microbial enumeration, and culturing
c. Knowledge of electronic documentation systems in a cGMP environment.
d. Knowledge of routine QC process including laboratory investigations and change controls.
e. Experience with hands on testing and sampling as well as fundamental theoretical knowledge of relevant assays.
f. Candidate must be able to work off shift and in a team environment.

Preferred Experience/Knowledge/Qualifications
b. Prior Quality Control experience preferred.
c. Exceptional attention to detail and strong writing skills are crucial.
d. Participation in various and assigned phases of Quality Control testing.

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