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Quality Assurance Specialist
$101k-123k (estimate)
Contractor 3 Months Ago
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Katalyst Healthcares & Life Sciences is Hiring a Quality Assurance Specialist Near Lancaster, PA

Responsibilities
  • Quality Assurance Specialists working in one of our distribution centers are responsible for enforcing our cGMP practices on-site.
  • Report any concerns or opportunities for improvement to the QA Safety & Facilities Manager.
  • Provide cGMP and controlled document training for new hires and refresher training annually for all warehouse departments and maintain training records.
  • Assist employees in submitting quality assurance policies and cGMP procedures.
  • Assist departments with coordinating audit information and recommend appropriate data-gathering mechanisms, procedures, etc.
  • Is familiar with cGMP standards and/or ISO certification in the same or related industry.
  • Document control expert for revision control, processing, and filing (hard copy and electronic).
  • Maintain Excel tracking logs and create matrix and reports to assist the Compliance Manager in evaluating trends.
  • Work with the Returns team on any customer complaint returns or undeliverable packages.
  • Perform daily and monthly DC audits/inspections and ensure any corrective actions from audits are closed.
  • Responsible for knowing current QA regulations pertinent to the dietary supplement industry and training and enforcing regulations within the distribution center.
  • Perform internal audits at the distribution center as required and ensure preparedness for regulatory on-site audits.
  • Assist the Senior Manager of Quality with managing quality issues such as product recalls, CAPAs, deviations, and adverse event reporting.
  • Maintain current and accurate records of all relevant communications, audits, corrective action plans, preventative maintenance, and effectiveness monitoring.
  • Perform other assigned duties as necessary within the realm of the Quality department.
  • Work independently in an on-site (not a hybrid/remote) role.
Requirements
  • Detail-oriented, organizational, and investigative qualities essential
  • Focused and self-starter mentality.
  • Excellent verbal and written communication skills
  • Interpersonal skills for successful interaction with company employees at all levels and possibly regulatory authorities
  • Expertise in using Microsoft programs (Word, Excel, PowerPoint).
  • Familiar with cGMP standards and/or ISO certification in the same or related industry.
  • Experience with an Inventory ERP system is a plus.
  • Associate degree required; Bachelor's degree preferred.
  • 2-3 plus years of related quality coordination experience in the same or related regulated industry.
  • Ability to work independently within the warehouse environment.
  • Comfortable dealing with upper management, auditors, etc.

Job Summary

JOB TYPE

Contractor

SALARY

$101k-123k (estimate)

POST DATE

03/27/2024

EXPIRATION DATE

05/27/2024

WEBSITE

katalysthls.com

HEADQUARTERS

South Plainfield, NJ

SIZE

<25

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