Quality & Regulatory Coordinator in Waukegan, IL at APEX Systems
Company: Apex Systems
Posted on: May 15, 2019
Job #: 959292
This position is responsible for the quality assurance review and
release of sterilized products. Process Challenge Pack (PCP) and
Process Challenge Device (PCD) manufacture to support sterilization
processes, R&D, validation and optimization projects as
assigned. Provide Certificates upon request. Perform invoice
processing and PO generation.
- Demonstrates knowledge of quality systems and approaches.
- Demonstrates an understanding of the relevant regulations,
standards and operating procedures.
- Perform investigations/root cause analysis and develop
- Gathers data to develop the sterilization and laboratory
- Demonstrates an understanding of the requirements and has the
ability to perform gap assessments to those requirements.
- Demonstrates an understanding of quality concepts such as: cost
of quality, analytical metrics and /or statistics, trending,
quality planning, validation, CAPA and problem solving.
- Works cross-functionally and has the ability to interpret the
requirements as well as educate and influence others on those
- Responsible for the review of sterilization batch records and
the release of sterilized production loads.
- Support of departmental invoice processing, ordering and PO
- Responsible for the generation of Certificates of Sterility and
issuing those certificates to customers as requested.
- Responsible for the tracking, trending and storage of data, as
- Assist with manufacture of Process Challenge Pack (PCP) and
Process Challenge Device (PCD) to support sterilization process
R&D, validation and optimization projects as assigned.
- Receives general direction on standard work; receives detailed
instruction on new assignments.
- Consults with supervisor or senior peers on complex and unusual
- Responsible for communicating business related issues or
opportunities to next management level
- For employees with supervisory responsibilities, ensure that
subordinates follow all Company guidelines related to Health,
Safety and Environmental practices and that all resources needed to
do so are available and in good condition
- Responsible for ensuring personal and Company compliance with
all Federal, State, local and Company regulations, policies, and
- Responsible for ensuring compliance with Quality Procedures,
Laws and Regulations of the applicable Markets
- Performs other duties assigned as needed
- High School Diploma or equivalent required; Bachelors degree,
- 1+ years experience in scientific or related field,
- Experience with invoice management, preferred
- Must possess experience with MS Office suite applications.
- Must be detail oriented and highly organized
- May need to work occasional overtime and support on weekends as
Apex is an Equal Employment Opportunity/Affirmative Action
Employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, age,
sexual orientation, gender identity, national origin, disability,
protected veteran status, or any other characteristic protected by
law. Apex will consider qualified applicants with criminal
histories in a manner consistent with the requirements of
applicable law. If you have visited our website in search of
information on employment opportunities or to apply for a position,
and you require an accommodation in using our website for a search
or application, please contact our Employee Services Department at
Keywords: Apex Systems, Waukegan , Quality & Regulatory Coordinator in Waukegan, IL at APEX Systems, Other , Waukegan, Illinois
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