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Quality Control Analyst

2 months ago

Clackamas, United States Health Wright Products Full time
Job DescriptionJob Description

INTERNAL TITLE : Quality Control Analyst II

PAY

Starting at $21/hr

**$43,680 per year

**Yearly rates vary per hours worked

SHIFT

Monday - Friday, 8:00AM - 5:00PM

BENEFITS

FOLLOWING MONTH after start date

  • Sick & Safe Time (prorated per start date)
  • Vacation Time (seperate from Sick & Safe, prorated per start date)
  • 13 Paid Holidays
  • Health Benefits
  • Company paid short term, long term, and accident-life insurance
  • 401k
  • Quarterly Performance-Based Reviews for yearly Merit Increase eligibility

After 6 Months

  • Eligible for Education Reimbursement Program

After 1 Year

  • 5% Annual bonus (granted per company goals)
  • COSTCO Membership (new hires can participate during our annual sign up/renewal period in March)

Qualifications

  • Bachelor’s degree and or 1 years’ experience working in an FDA regulated, GMP production facility
  • OR Associates degree and 2 years' experience working in an FDA regulated, GMP production facility
  • OR in lieu of degree 5 year or more experience working in Quality in an FDA regulated, GMP production facility
  • Experience working in a warehouse and manufacturing environment.
  • Experience in Six sigma or lean manufacturing practices preferred.
  • Forklift certified and/or willingness to be forklift certified.

REQUIREMENTS

  • A legal right to work in the United States
  • Must pass pre-employment drug screen and background check
  • For those applying out of the area We love working for such an awesome company within the beautiful Pacific NW and understand your motivation is to do the same Please recognize that relocation packages are not being offered at this time.

Job Summary

The primary responsibility is to inspect Finished Goods to ensure only Finished Goods that meet specification of premium quality are released for distribution. Responsible for performing a manual and visual inspection of products for final packaging using AQL sampling plans. The Analyst is responsible for ensuring compliance with internal procedures, policies, standards, FDA regulations, and quality systems.

  • Determine if requirements for Finished Goods are within specification. Perform final review on batch records to support the release of the finished products.
  • Perform and document AQL inspections as directed.
  • Determine if the lot is within the specification range for each physical test.
  • Document results as part of the Quality product release process.
  • Interface with Engineering, Quality, and Operations to communicate quality standards and address issues in a timely manner.
  • Control nonconforming material and assist in release of quarantine product, which includes creating, verifying, and closing nonconforming materials reports. Responsible for documenting and internal non-conformances and out-of-specification conditions.
  • Support the Label Specialist, assist with release and stickering printed packaging materials.
  • May act as back-up to the Quality Analyst II in releasing finished product
  • Communicate effectively regarding any non-conformance issues in a timely fashion to Account Management, Operations and Quality.
  • Per established procedures and guidelines, review relevant documentation, ensure deviations are applied to work orders, and generate MMR packets.
  • Other duties as assigned
  • 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.