Quality Specialist

Health Wright Products is a privately held Contract Manufacturer of Nutritional Supplements that is seeking a Quality Specialist to join our expanding organization. After 25 years of significant growth we are still just at the beginning cycle of our potential and you would be joining a talented and committed team!

PAY

50k-60k, DOE

SHIFT

Monday – Friday, Office Hours

JOB SUMMARY

This role is responsible for ensuring the Complaint and CAPA systems are being managed effectively.

A. Aid in writing Consumer complaint investigation, metrics reports. Present data through meetings and as written documents. Propose appropriate CAPAs to avoid reoccurrences.

B. Administers CAPA system focusing on CAPA approval, closure and database tracking.

C. Maintain internal SharePoint sites for tracking Complaints and CAPAs.

D. Conduct Internal Quality Audits, lead internal audit teams. Report observations and other potential concerns to auditees and management, both through verbal presentation and written audit reports.

E. Aid in the completion of action items generated due to deviations and change control requests.

F. Support external audits.

G. Compiles data for trend analysis for complaints, deviations, and CAPAs.

H. Support the development, implementation, and continuous improvement of Quality System CAPA procedures, CAPA tracking, and CAPA training.

I. Employ program management skills to ensure implementation of adequate controls and corrective actions to prevent recurrence of nonconformances. Develop and apply statistical methods for verification of CAPA effectiveness.

J. Ensure that CAPA records are complete and they contain accurate links and references to other Quality processes such as Change Management, Non-Conformance, and Complaint Handling

K. Other duties as assigned.

L. Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job. Must re-qualify every year on all job-related tests and certifications as job or qualifications require

QUALIFICATIONS

A. A.S. degree or higher in Chemistry, Biology, Food Science, or related discipline.

B. Project management or similar experience preferred.

C. Experience working in a manufacturing environment.

D. Root cause analysis and corrective/preventative action experience preferred.

E. Experience in Six sigma or lean manufacturing practices preferred.

F. Technical writing skills.

G. Familiar with Microsoft applications such as MS Office.

H. Experience with FDA/cGMP compliance is preferred.

I. Ability to work independently.

J. Requires a well-developed ability to read, write, and communicate in English in relation to topics of a complex or technical nature.

K. A legal right to work in the United States.

A. Must pass a drug screen and a background check in accordance with HWP standards.

BENEFITS *after 90 days

Health Wright Products offers a generous benefit package including medical, dental, vision, short term disability, Critical Illness Insurance, Accident Insurance, life insurance plans and pet insurance. In addition, HWP offers its employees a 401k plan with company matching funds, FSA, and tuition reimbursement. Paid time off benefits for employees include holidays, vacation and PTO (personal time off).

For those applying out of the area: We love working for such an awesome company within the beautiful Pacific NW and understand your motivation to do the same! Please recognize when applying for our positions that relocation packages are not being offered at this time.

For those applying out of the area: We love working for such an awesome company within the beautiful Pacific NW and understand your motivation to do the same! Please recognize when applying for our positions that relocation packages are not being offered at this time.

Thank you for taking the time to get to know us & we look forward to learning more about you!


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