Quality Control Technician
Company: Forge Biologics
Location: Columbus
Posted on: February 23, 2021
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Job Description:
We are currently seeking a Quality Control (QC) Technician to
join the Forge Biologics team. This is an exciting opportunity to
lead the laboratory efforts and execute characterization testing
and assays for Quality Control. The candidate will optimize
existing and implement new technologies and systems into Quality
Control for research and GMP purposes. The ideal candidate will be
skilled in technical problem-solving and laboratory techniques to
support our growth in the Gene Therapy sector.The QC Technician may
be responsible for performing the in-process and release testing
for our most advanced AAV-based (viral vector) therapeutic
candidates generated from the PD, research, and GMP laboratories,
as well as raw materials, to ensure they conform to manufacturer
specifications. The QC Technician will execute the procedures
designed to demonstrate safety, efficacy, and purity of the drug
products under evaluation.The QC Technician may be responsible for
upstream (cell culture and virus production) and downstream
(harvest and purification) testing activities to support a singular
"platform" process for the entire AAV program
portfolio.Responsibilities:* Conducts Environmental
Monitoring/Microbiological, Chemistry, and/or Biochemistry testing
(e.g., microbial testing, titering by PCR, etc.) that incorporates
application of GMP principles and methodologies.* Conducts thorough
investigations to determine root cause of OOS investigations and
other non-conforming results and implements appropriate corrective
and preventative actions in a timely manner.* Drafts and revises
process documents, assay methods, and sampling plans.* Trains
junior staff in laboratory skills and scheduling lab/equipment
maintenance.* Plans work to meet production and schedule
requirements from clients (internal and external).* Prepares and
presents data associated with manufacturing processes and transfer
activities to clients. May serve as the Person-in-Plant (PIP)
support during manufacturing campaigns.* Reviews and trends QC data
(environmental monitoring, microbiological, chemistry, and/or
biochemistry) and publishes trend reports on a routine basis.*
Supports internal process transfer activities and serves as Subject
Matter Expert (SME) to troubleshoot processes/assay. May also
represent QC as a SME during audits and inspections.* Delivers
results in a high paced environment.* Supports packaging and
shipping finished product and/or coordinates the effort.*
Additional responsibilities not listed may be assigned as needed by
management.Requirements:* Minimum Bachelor's Degree (B.A. or B.S.)
in scientific-related field or engineering (or equivalent work
experience).* Minimum 2 years' experience in a Quality Control
laboratory; GMP QC laboratory strongly preferred.* Must be
self-motivating, organized, and proactive.* Strong technical
aptitude, including demonstrated experience in applying scientific
reasoning to solve complex problems.* Ability to work hours
necessary to support production and/or product transfer
activities.* Ability to work in confined spaces and near operating
equipment.* Ability to work in loud noise environments and in
Personal Protective Equipment (PPE) and Clean Room gowning attire
as needed.* Travel on an infrequent basis is required (5%) to
support job responsibilities and commitments.Special Knowledge or
Skills Preferred.* Detailed/Demonstrated knowledge and
understanding of GMP regulations and Food and Drug Administration
(FDA) requirements.* Experience with an electronic Document
Management System.* Working knowledge of global pharmacopeias such
as USP, EP, JP, BP, Ph. Eur.* Knowledge of biopharmaceutical
manufacturing process workflows.* Knowledge in the following
system(s): Cell Culture and Cell-based assays, Pharmaceutical
Utilities, HPLC, Microbial testing, Mass spectrometry, AUC, PCR,
ELISA, and gel electrophoresis.*
Keywords: Forge Biologics, Columbus , Quality Control Technician, Professions , Columbus, Georgia
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