Specialist, QC Micro
Company: Theragent, Inc.
Posted on: August 4, 2022
Specialist, QC Micro
What We Do
Theragent is a privately-owned Contract Development and
Manufacturing Organization (CDMO) focused on novel Cell and Gene
Therapy medicines to meet unmet patient needs. We are a small,
biotech startup headquartered in Arcadia, CA. Our state-of-the-art
facility provide high-quality, reliable, and value-added solutions
to our clientele for challenging pre-clinical and clinical trial
projects. Our innovative cGMP facility offers comprehensive
end-to-end manufacturing and testing capabilities for clinical and
Take the next step in your career and join Theragent today to
change patient lives through the products we help develop and
manufacture. Here, you will contribute your talents in a purposeful
way that impact the lives of patients around the world. You will
develop as an individual by working directly with a team of
seasoned experts and rising stars. Our values of Innovation,
Transparency, Accountability, Integrity, Diversity, Humility to
name a few are embedded in everything we do. No matter your role
may be, Theragent strives to ensure all our teammates are empowered
and given the necessary tools to lead us in our relentless pursuit
to extending patient lives.
To Manufacture and Deliver high-quality, reliable, and value-added
Therapeutic Solutions for Biopharma clients and patients.
The Specialist, QC Micro has a unique opportunity to play a key
role in building of the QC Microbiology laboratory from ground up
for a Cell and Gene therapy biotech startup.
The Specialist, QC Micro will assist in the method transfer and
validation studies, support commissioning new equipment, support
revising and editing Quality system procedures, assist continuous
improvement initiatives, and support QC on project teams for
clinical and commercial products. Working with QA, manufacturing,
and analytical development groups, the Specialist, QC Micro will be
responsible for meeting QC timelines related to deliverables such
as method transfer reports, test methods, change controls, and
validation protocols and reports.
The Specialist, QC Micro will assist and support in the day-to-day
operation of cGMP compliant Quality Control Microbiology laboratory
of Theragent Inc to include performing and providing support for
functional aspects of the facility such as environmental and
utility monitoring (EM), microbiological testing, media fills,
water testing, and other activities that will support execution of
testing for cGMP samples for in-process, lot release and stability
samples in-house. This role will be responsible for documentation
that is compliant with all applicable procedures, standards, and
cGMP regulations. The QC Microbiology Laboratory is a highly
controlled environment, where significant attention must be paid to
written procedures, safety, and cGMP compliance. Schedules and
completing testing on time error free are of paramount importance.
The lab is equipped with highly sensitive and expensive instruments
which must be handled with care.
- Assist the transfer and validation of test methods in support
of drug substance release and stability testing.
- Revise test methods, validation protocols and reports, Quality
system SOPs, and other supporting documents.
- Support equipment onboarding and validation lifecycle,
including operation and maintenance procedures and software
- Assist initiating change controls, support investigations,
CAPAs, and continuous improvement initiatives to successful
- Represent QC Microbiology on project teams for clinical and
commercial products with primary responsibility for validation of
Drug Substance release assays.
- Support performing validation of microbiological assays and
assist provide training related to in-process and drug substance
testing, equipment, environmental and utility monitoring to include
Bioburden, Endotoxin, Growth Promotion testing, etc.
- Assist and support to perform environmental and utility
monitoring of the cell and gene therapy production facility
according to written procedures while fully gowned including
operational monitoring and personnel monitoring during aseptic
processing, and aseptic filling.
- Assist and support to perform routine environmental monitoring,
as needed to meet schedules.
- Read environmental and utility monitoring plates by counting
- Fill out appropriate reports and forms
- Assist to perform microbial identification like gram stains,
- Track all data and complete in a timely manner.
- Perform all activities in compliance with cGMP
- Assist preparation and presentation of quarterly and annual
reports, trend investigations, statements of quality, and other
applicable reports to management.
- Support onboarding and qualification of laboratory equipment
and GMP software systems.
- Generate and write SOPs and protocols related to test methods
involving product lot release.
- Draft technical documents including test methods, validation
documents, and deviations.
- Assist implementation of change controls, support
investigations, and complete CAPAs in support of GMP
- Assist in purchasing all necessary supplies, needed for QC
- Assist to receive supplies, log-in and store appropriately
following written procedures.
- Assist to perform growth promotion analyses on all
microbiological media lots received.
- Report results on appropriate forms. -
- Inspect and clean the laboratory and its equipment on a regular
- Perform laboratory and equipment cleaning, preventative
maintenance and calibration as described in written procedures.
- Follow written procedures for cleaning.
- Record all necessary information and maintain current,
accurate, legible records of all work performed.
- Report problems to management in a timely manner and support
finding creative solutions to resolve them.
- Ensure compliance to all quality requirements to meet audit
standards and regulatory compliance.
- Maintain lab equipment, reagents inventory, and documentation
to ensure accurate, timely, and cost-effective analysis of
materials and products.
- Assist creating training materials and training staff on
methods and related SOPs.
- Support implementation and qualification of current and new
pharmacopoeia methods to ensure compliance with cGMP's and other
- Assist analyzing and summarizing data into reports and
certificates of analysis with attention to details.
- Participate in risk assessments such as HAZOP's and
- Assist proposing corrective and preventive actions and
improvements identified through investigations and audits and
assist performing effectiveness checks of CAPA's.
- Perform sample management tasks, including labeling, shipping
to external labs, inventory, and disposal of samples.
- Participate in collaboration meetings with external clients,
contractors, and vendors.
- Participate in internal audits and external audits and support
providing responses and implementation of actions related to
- Other duties as assigned by management.
Reports to: Associate Director of QC Microbiology
FLSA Status: exempt
Location: Arcadia, CA
Knowledge, Skills & -Abilities:
- Demonstrated in-depth knowledge of Microbiological methods
across a wide range of technologies.
- Proven scientific and technical ability to design and execute
method development and validation experiments; analyze and present
data; author and review protocol and reports, in support of
- Demonstrated deep knowledge and experience of cGMP and the
regulatory requirements for pharmaceuticals.
- Must be a highly motivated and self-driven individual with the
ability to work independently, and multi-task under aggressive
timelines to support department and business objectives
- Very good analytical, technical writing, communication, and
data management skills
- Demonstrated expertise with a range of Microbiological test
methods including Bioburden, Endotoxin, Environmental and Critical
Utility Monitoring, Growth Promotion, Water analysis.
- Knowledge of cGMP, ICH, pharmacopoeia, and regulatory
requirements for testing and validation pertaining to the
pharmaceutical industry is required.
- Other regulatory agencies experiences preferred
- Experience in the qualification of cell therapy equipment a
- Knowledge of pharmaceutical, manufacturing and laboratory
systems and equipment
- Working knowledge of Deviations, Change Controls, and
- Basic knowledge of Compendial (i.e., USP, EP, JP, etc.)
requirements and standards
- Strong understanding of Microbiology related to drug substance
or drug product manufacturing.
- Strong written and verbal communication -skills
- Very good interpersonal and teamwork skills with experience
dealing with all levels within the company
- Willingness to collaborate internally and with clients while
- Strong multi-tasking ability in conjunction with proven
organizational and record keeping skills
- Ability to organize assigned tasks in a high paced environment
and monitor tasks / assignments that -may -impact timely
- Ability to -effectively manage -multiple tasks -and activities
- Proficient -computer -skills in Microsoft Office Suite - Word,
Excel, -PowerPoint, and Outlook.
- Innate ability -to learn new software, such as corporate
intranet -and enterprise business
- Strong team player, able to meet deadlines and changing
- Understanding of cGMP regulations, preferably with Cell
Education & Professional Experience:
- Bachelor's degree in Microbiology, Molecular and Cell biology,
Biology or related field required. In lieu of this requirement,
work experience may be considered
- Minimum of 5 years of work experience in the Pharmaceutical,
Life Sciences industry with cGMP, GLP A strong background in method
development, qualification and validation is highly desired.
- A background in quality control testing related to
Biopharmaceuticals is required.
- Experience with problem solving methods such as DMAIC or other
similar Root Cause Analysis Tools
- Experience with electronic Laboratory Information Management
- Experience with relevant microbiology laboratory equipment and
- Laboratory environment
- Must wear PPE due to safety requirements in designated lab
- May be required to work in controlled or clean room
- Must be able to read, write, and converse in English
Travel: Occasional. Less than 10%
Physical / Mental Demands:
- Occasional stooping, -bending, stretching, pushing, pulling,
reaching and/or lifting up to 25lbs.
- Ability to sit, stand, walk, -and move within -workspace for
- Ability to perform repetitive -tasks including hand to finger
manipulations, grasping, pushing, -and pulling
- Primarily GMP process clean room environment but will be
required to enter laboratory areas donning proper gowning / lab
coats or PPE such as safety glasses, gloves, face masks and
- Ability to work safely -and effectively -when working alone or
working -with others
This description outlines the basic responsibilities and
requirements for the position noted. This is not a comprehensive
listing of all job duties of position. Duties, responsibilities,
and activities may change at any time with or without notice.
Theragent, Inc. is an equal opportunity employer and prohibits
unlawful discrimination based on race, color, religion, gender,
sexual orientation, gender identity or expression, national origin
or ancestry, age, disability, marital status, and veteran status.
All qualified applicants will receive consideration for
Theragent, Inc. requires employees to be vaccinated against
-COVID-19. To the extent permitted by applicable law, candidate
must be able to provide proof of full -vaccination -or receipt of
the first dose of a two-dose -COVID-19 -vaccine, or request an
exemption due to a medical reason, a sincerely held religious
belief of practice, or pregnancy, as of the first day of work, to
be considered for a U.S.-based job. -
Keywords: Theragent, Inc., Arcadia , Specialist, QC Micro, Other , Arcadia, California
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