Quality Assurance Specialist, Katalyst Healthcares and Life Sciences, Lancaster, PA
Katalyst Healthcares and Life Sciences -
Lancaster, PA,
US
Quality Assurance Specialist
Date Posted: 2024-05-08
Job description
Responsibilities:
Requirements:
- 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.
- ssist employees in submitting quality assurance policies and cGMP procedures.
- ssist 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.
- ssist 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.
- ssociate degree required; Bachelor's degree preferred.
- 2-3 plus years of related quality coordination experience in the same or related regulated industry.
- bility to work independently within the warehouse environment.
- Comfortable dealing with upper management, auditors, etc.