Quality Control Inspector
Company: Swiss American CDMO
Location: Carrollton
Posted on: August 6, 2022
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Job Description:
Quality Control Inspector Position Summary:Under supervision of
the Quality Control Supervisor, the Quality Control Inspector (QCI)
is responsible for assuring that all products produced at Swiss
American Products conforms to all regulatory and quality
specifications. In doing so, the QCI will monitor production, test
bulk compounded product and complete other duties as
required.Essential Duties and Responsibilities
--- Perform pre-production line inspections to ensure that all
manufacturing lines are clear of materials from previous runs and
is acceptable for use.
--- Complete routine production line checks to check and accurately
document finished good product for fill weights, visual conformity,
and/or seal inspection
--- Collect, document and prepare samples for shipment for
microbial and chemical testing.
--- Ensure that all operations in production areas are performed in
accordance to SAP SOP's and FDA l GMP guidelines.`
--- Assist in execution of product/process validation
activities.
--- Collect and analyze appropriate samples for the release testing
of finished goods and bulk product (Le. pH and Viscosity).
--- Monitor all activity on the production floor to assure
adherence to SAP SOP's and applicable FDA l GMP regulations.
--- Participate in investigations for process deviations and
product quality failures and assist in implementation of corrective
actions.
--- Print and release finished good case labels to production
personnel.
--- All other duties and responsibilities assigned.Limits of
Authority: Interprets work situations and expectations, handles
issues which conform to Company policy and past practice, and
refers extraordinary situations to the Quality Control Supervisor
or Quality Control Manager for guidance when
necessary.Qualifications: To perform this job successfully, an
individual must be able to perform each essential duty
satisfactorily. The requirements listed below are representative of
the knowledge, skill, and/or ability required. Reasonable
accommodations may be made to enable individuals with disabilities
to perform the essential functions.Education/Experience:High School
Diploma or equivalent. Associates degree desired.Language
Ability:Must be able to explain processes and effectively implement
processes as outlined by SAP protocol.Math Ability:Must be able to
understand rounding rules and significant figure rules. Ability to
apply concepts such as fractions, percentages, ratios, and
proportions to practical situations.Reasoning Ability:Must be able
to adequately understand SAP protocol and apply to various
production processes as it applies to specific procedures. Must be
able to deal with a variety situations, including stopping
production if the continuation of production would compromise the
integrity of the finished good.Computer Skills:To perform this job
successfully, an individual should have knowledge of Microsoft
Office Business Suite and Internet software.Certificates and
Licenses:No certifications neededSupervisory
Responsibilities:N/AWork Environment:The work environment
characteristics described here are representative of those an
employee encounters while performing the essential functions of
this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential
functions.The noise level in the work environment is usually
moderate.Physical Demands:The physical demands described here are
representative of those that must be met by an employee to
successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions. Must be able to
lift up to 50lbs on a regular basis.
Keywords: Swiss American CDMO, Carrollton , Quality Control Inspector, Other , Carrollton, Texas
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