Sterility Assurance Specialist I
Company: WuXi AppTec
Location: Philadelphia
Posted on: October 12, 2024
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Job Description:
Responsible for producing documents for sterility assurance
related programs, providing aseptic processing oversight, and
technical support to manufacturing operations to ensure
contamination control. Acts as the Primary Sterility Assurance
Representative and effectively collaborates with multi-disciplinary
teams for designated projects. -Position Details:Monday to Friday
Standard Business Hours100% Onsite at our Philadelphia, PA
location--- Authors and reviews qualifications such as
environmental monitoring performance qualification (EMPQs), aseptic
process validations (APVs), and airflow visualization (smoke
studies).--- Owns change control tasks associated with
qualification or program revisions--- Authors risk assessments in
support of microbial control strategy and sterility assurance
programs--- Performs aseptic processing training for manufacturing
and support personnel --- Participates in continuous improvement
and implementing best practices (ensuring understanding/ compliance
with SA related regulations and guidance--- Performs regular GEMBA
style assessments of the aseptic process on site to assess
compliance of operations including identification of deficiencies
and provide real time coaching to aseptic staff--- Authors new and
revised procedures for Sterility Assurance department. --- Data
approval in EMDS system --- Coordinates with Project teams in
design, set up and execution of projects --- Maintains current
regulatory knowledge, staying up to date with best practices and
sharing knowledge --- Participates in business excellence projects
within SA and across site--- Ability to work in a team environment
and independently as required--- Maybe required to work Holidays
and weekends--- Bachelor's degree with a major in Biology,
Microbiology or related Life Science --- 3-5 years relevant
technical experience -Knowledge / Skills / Abilities:--- Knowledge
of GLP and cGMP guidelines is required. --- Ability to make
decisions based on a wide knowledge of factors where application of
advanced or technical concepts is predominantly required.---
Ability to evaluate technical data and write technical
documents.--- Ability to use judgment as dictated by complexity of
situation.--- Ability to work under limited supervision and to
handle problems of a difficult nature.--- Ability to accomplish the
described duties through the use of appropriate equipment and
software.--- Ability to accurately and reproducibly perform
arithmetic calculations including fractions, decimals and
percentages and basic algebraic and geometric calculations.---
Ability to record data accurately and legibly.--- Ability to
understand and follow verbal or demonstrated instructions.---
Proficient in Oral & Written communication skills--- Need to be
able to read, write and understand English--- Proficient in
Microsoft (Excel, Word, Outlook) -Our Values:Integrity &
Dedication, Working Together & Sharing Success; Do the Right Thing
& Do it Right. -Our greatest asset is our people, WuXi is dedicated
to providing opportunities for internal growth with direct access
to a dedicated and accessible Human Resources team. -WuXi AppTec
provides equal employment opportunity to all individuals regardless
of their race, color, creed, religion, gender, age, sexual
orientation, national origin, disability, veteran status, or any
other characteristic protected by state, federal, or local law.
Keywords: WuXi AppTec, Cherry Hill , Sterility Assurance Specialist I, Other , Philadelphia, New Jersey
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