Pharmaceutical Quality Assurance Specialist
Company: Ingredion
Location: Bedford Park
Posted on: April 28, 2024
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Job Description:
As a Pharmaceutical Quality Assurance Specialist, API your
responsibilities will include:Perform batch record review on all
API and NF batches.Monitor the day-to-day quality activities of the
API to produce and package products of sufficient quality and
quantity that meet the requirements of customers and regulatory
bodies.Assist in deviation investigation program.Compile and
approve summaries of API and NF product OOS
InvestigationsCoordinate, review, approve and coordinate validation
(lab, process, and method), qualification (DQ/IQ/OQ/PQ) and
requalification activities. Use expertise to ensure
methods/process/equipment/systems remain in a validated
state.Analyze historical data, for key efficiencies and parameters
against design to assist with troubleshooting and meeting Quality
KPIs. Supports customer and regulatory audits as necessary.Being on
call for off shift, weekends, and holidays as required.Conduct
annual product reviews for API and NF products.Coordinate stability
studies.Design and conduct training covering Pharmaceutical cGMPs
and other regulatory requirements.Generate and analyze various
quality metrics as needed.Assist in various quality activities as
required.Assist in the quarterly compliance of API laboratory
systems.Participate as auditor in the GMP and internal audit
programs.Schedule Annual Product Review meetings with upper
management and review results. Recommend course of action following
conclusions drawn from annual review data analysis.Implement any
corrective actions needed following any deficiencies found during
batch record review, OOS/deviation investigation mock audit
exercises.Oversee the management of change program for the active
pharmaceutical ingredient.Assist the deviation investigation
program and ensure compliance to the quality management, customer,
and regulatory requirements. Coordinate & lead weekly meetings with
Operations, Maintenance, Engineering and Quality Control groups for
timely action completion.Able to contribute as a team member on
Lean Six Sigma (LSS) projects.Quality representative for the Active
Pharmaceutical Ingredient unit.The Quality Assurance Specialist,
API position is well-suited for you if you have:Ability to
prioritize and plan to support the QA team.Ability to manage
control processes to meet regulatory requirements.Ability to work
with others to maintain system changes, upgrades and managing
control documents. Ability to provide leadership and guidance to
operations and management staff.
Qualified candidates will have:Bachelor of Science Degree (i.e.,
Engineering, Chemistry, Microbiology, etc.) or significant
experience in quality assurance/control, operations, analytical or
other technical functional area.Three to five years' experience
working in QA with pharmaceutical ingredients or
products.Experienced with ICHQ1, ICH Q7, ISO9001, 21cfr 210 and 211
HACCP, Food Safety and training.Excellent oral, written, and
communication skills. Strong computer skills with proven
proficiency in Microsoft Word, Excel, Power Point, Visio,
flowcharting software and experience with Electronic Documentation
Systems a plus.Strong interpersonal skills to execute and navigate
day to day tasks. Relocation Available?
No Job Grade:
E What is the formula for a winning career?It starts with joining a
thought leader, innovator and true high performer, grounded in
values and driven to innovate and advance. As a Fortune 500 global
provider of ingredient solutions, Ingredion offer great careers
across various functions-corporate, scientific, engineering and
operations, sales and technical service, marketing and more.
If you are curious, confident, and believe in the power of
game-changing ideas, we want you to make us part of your career
formula. Successful: Grow with a leader.
Ingredion is FORTUNE 500 company with consistently strong financial
performance.Responsible: Thrive with an organization that lives its
values.
We drive relentlessly toward sustainable practices and responsible
operations wherever we do business.Meaningful: Be proud of where
you work and what you do.
Ingredion enables innovation in foods, beverages and consumer
products that touch lives around the world.A career at Ingredion
combines the benefits and professional opportunities afforded a $7
billion leader in our industry with the dynamic environment and
team-driven culture you'd expect in a much smaller company.
Despite its global scope and the advancement opportunities that
come with it, Ingredion has the intimacy of a mid-size company, one
where different perspectives are sought and where relationships
matter.We are an equal opportunity employer and value diversity at
our company. Ingredion seeks to provide a work environment that is
free from harassment and discrimination. We will not tolerate any
form of discrimination based on race, color, religion, age, gender,
gender identity, gender expression, national origin, ancestry,
handicap or disability-mental or physical-marital status, sexual
orientation, veteran status, disability resulting from military
service, or any other classification protected by law ("protected
classifications"). We are committed to establishing and maintaining
a work environment where everyone is treated with dignity and
respect.Relocation Available: Yes, Within Region
Keywords: Ingredion, Bartlett , Pharmaceutical Quality Assurance Specialist, Healthcare , Bedford Park, Illinois
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