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Senior Quality Systems Specialist Job

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Primary Location: Greenville, SC

Job Tile: SENIOR QUALITY SYSTEMS SPECIALIST

Job Number: 2017-46338

Date Posted: 11-7-2017

Job Summary

The Senior Quality Systems Specialist will ensure company compliance as it relates to customer requirements, internal Nutra requirements, and all applicable regulations. S/he will provide leadership and support to Manufacturing and Packaging operations with regards to deviation/non-conformance investigations and Root Cause Analysis. The Senior Quality Systems Specialist will help educate others on the process of deviation/non-conformance investigations as well as Root Cause Analysis and CAPA development. S/He must remain objective and maintain high standards of ethics, honesty and urgency required to meet the quality standards, objectives and goals and be able to work with all levels of Associates. Will also support Quality team in various other quality related functions to include review of documents, SOP Review/Creation, preparation of reports, preparation of metrics and improvement teams.

Essential Duties and Responsibilities

STRATEGIC

  • Manages communication and relationships with Manufacturing and Packaging with regards to investigations, root cause analysis, and CAPA development.
  • Accountable for implementation of training for deviation/non-conformance & CAPA documentation for Nutra Personnel.
  • Create strategy for improving Nutra's Root Cause Analysis and documentation process within QMS system by defining deviation/non-conformance Categories and RCA categories leading to value adding metrics.
  • Recommend methods for improving processes based on analysis of deviation/non-conformance trends
  • Manage oversight of CAPA Review and Approval process to ensure that commitments for Audit, Deviation, Complaint and other CAPAs are met. Review Overdue CAPAs and expedite completion of CAPAs with appropriate internal stakeholders. Reset CAPA due dates when appropriate justification provided by responsible individuals.

TACTICAL

  • Mentors employees at all levels in quality policies and procedure & provides Quality support and leadership to Manufacturing and Packaging
  • Interacts with Customers as needed regarding deviation/non-conformance investigations
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
  • Will assist in authoring RCA investigations as needed and become a SME for Nutra in RCA investigations.
  • Ensures CAPAs created in response to root cause investigations are appropriate and effective.
  • Review and approval of deviation/non-conformance investigations in the QMS system.
  • Revise/Author SOP & Work Instructions for Quality as needed. Assist manufacturing and packaging with SOP & Work Instruction creation/updates.
  • Assist with QMS software system operation to detect potential problems
  • Provide technical guidance or support on the use of the QMS software system
  • Evaluate current or emerging systems to consider compatibility or usability and interfacing capabilities of the QMS software system.
  • Participate in and/or lead continuous improvement projects as required
  • Assist with Customer/Regulatory Audits, as necessary

Other Tasks as assigned by the Quality Systems Manager

Job Specifications

Minimum

· 3+ years experience in a similar role in a GMP environment

· 3+ years experience using Microsoft Office products

Preferred

· 5+ years experience in quality in a GMP or FDA regulated manufacturing environment

· 2+ years experience managing deviation/non-conformance investigations

· 2+ years experience in reviewing and approving cGMP related documents (SOPs, protocols, reports, investigations, etc.)

Education

Minimum

· Associates/Bachelor of Science in Food Science, Biology, Microbiology, Chemistry or related field or equivalent related work experience

Preferred

· Applicable certification (i.e. ASQ CQE) desirable

· Self-motivated, effectively work with others in various disciplines and ability to prioritize tasks in a deadline-driven environment

· Strong organizational and written/verbal communication skills

· 21 CFR Part 111 knowledge and other applicable regulatory cGMP knowledge

· RCA training/experience in a cGMP environment

Qualifications

· Self-motivated, effectively work with others in various disciplines and ability to prioritize tasks in a deadline-driven environment

· Strong organizational and written/verbal communication skills

· 21 CFR Part 111 knowledge and other applicable regulatory cGMP knowledge

  • Ability to function and communicate effectively at both strategic and tactical levels with all members of management
  • High ethical standards
  • Models and supports organization's goals and values

Licenses Registrations

None Required.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear and sit. The employee is occasionally required to reach with hands and arms. Specific vision abilities required by this job include close vision.

Standing, walking and sitting in office cubicle.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

Personal protective equipment as required. Manufacturing, laboratory and office environment.

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Sonya, Senior Demand Planner/Account

The GNC brand immediately attracted my attention. It was an opportunity to work

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