Quality Assurance Manager

2 months ago

Monroe Township, United States ClinLab Staffing Full time

POSITION SUMMARY:

This position will be responsible for working with the Quality Assurance Manger to support tasks including but not limited to supporting training program, complaints, nonconformities, CAPA, Supplier Management and document management. This includes monitoring and achieving department metrics and cycle times with adherence and compliance to cGMP/USP/ ISO and FDA guidance’s and requirements.

ESSENTIAL FUNCTIONS:

  • Assure Test Method SIPs, SOPs, Material Specifications, etc. are up-to-date and manuals are current.
  • Monitor the effectiveness of training by ensuring the employees are adequately trained to perform their job duties.
  • Support document complaint investigations, evaluate and analyze trends of complaints.
  • Assist in the product return for complaint investigation, and replacement processes as needed.
  • Manage deviations/nonconformities and identify appropriate root cause(s) and assess quality impact.
  • Manage CAPA process and follow-up to ensure CAPAs implemented are effective.
  • Support all remediation and continuous process improvement activities and plans.
  • Ensure that all data is organized and archived per appropriate workflows and SOPs.
  • Interpret and implement applicable standards, regulations and QMS documents effectively and accurately.
  • Establish, monitor, and improve critical KPIs in the QC lab related to invalid OOS, analyst error, training, testing plans, release metrics, and stability testing.
  • Provides support during internal and regulatory audits.
  • Gather, trend, and assess data and maintain metrics for Quality Assurance.
  • Perform prompt DHR review in compliance with FDA regulations and Good Documentation practices.
  • Write/update SOP’s as needed pertaining to QMS and applicable regulations.
  • Other QA duties and projects as directed by the Director, QM.

QUALIFICATIONS:

  • A minimum of Bachelor’s degree with 5-7 years of experience in a Quality Assurance role in GMP regulated Pharmaceutical/Medical Device/Consumer goods industry.
  • Prior experience working in electronic documentation systems preferred but not required.
  • Prior experience handling FDA or other GMP audits is a plus.
  • Strong leadership skills focusing on technical issue resolution, improved lab performance, effective collaboration, flexibility and multitasking of projects and priorities.
  • Extensive and strong analytical knowledge in performing investigations.
  • Good documentation and organization skills.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Strong interpersonal and written/verbal communication skills
  • Detail-oriented and organized
  • Analytical and problem-solving skills
  • Ability to multi-task and be adaptable
  • Proficient using Microsoft Office Applications
  • ISO/CQA certification is a plus

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