QA Compliance Specialist

LocationBrookfield, Connecticut
LocationShelbyville, Kentucky
DepartmentQuality
Reports ToQA Compliance Manager
Position Overview

Quality Assurance Compliance Specialist will report directly to the Quality Assurance Compliance Manager.  The specialist is responsible for supporting the Quality Management System by ensuring compliance with established procedures and quality/business requirements.

Duties & Responsibilities
  • Management of Change
    • Subject Matter Expert of Program.
    • Act as the QA representative in pre-submission meeting and assist initiator/project owner in completing the MOC form in meeting.
    • Maintain status updates on MOC Log, obtain any necessary approvals, follow up with initiators/project owners on status action items, and verify effectiveness.
    • Adhere to GMP Requirements.
    • Write customer notification letters and notify internal customers of change. Work with Marketing Department for notification of external customers.
  • CAPA (Corrective and Preventative) Management
    • Subject Matter Expert of Program.
    • Maintain CAPA Log including customer’s complaints and incidents.
    • Work with department managers/assigned parties to write action plans when needed.
    • Review and approve root causes and action plans, gather evidence, verify effectiveness.
    • Work directly with key accounts on customer complaints and quality concerns.
    • Review trends and communicate concerns
  • Prepare and Distribute Corporate Metrics
    • Work with Management to pull applicable data.
    • Review data for accuracy and trends and provide to Top Management.
    • Complete Metric Dashboard and distribute to the company.
    • Conduct Monthly Review Meeting with Management.
  • Quality Management Related Trainings
    • Create and administer training associated with the QMS and other Quality Compliance related topics.
  • Quality Management Inputs
    • Participate and support QA Compliance Manager with Audits associated with ISO, EXCiPACT (GMP), and the Organic Program.
    • Support QA Compliance Manager with updates made to Organic and Non-GMO Verified Program.
    • Maintain Quality Agreement Process with Customer, Legal and Quality.
  • Management of Triennial Documentation Review
    • Ensure compliance with the Triennial Documentation Review process.
    • Process documents through the Change Control Process.
  • Internal Auditor
    • Conduct Internal Audit, write report, distribute report and assign corrective actions if necessary.
  • Maintain Certificate Tracking Spreadsheet
    • Keep Certificates updated per RG114, Certificate Tracking Spreadsheet. Including all Kosher, State and TTB Requirements
  • Management of Document Review Committee
    • Responsible to lead meetings and assist in properly reviewing Procedures
  • Change Control Process
    • Manage and Process Change Controls for Standard Operating Procedures, Work Instructions and Forms. Includes receiving appropriate approvals, reviewing for applicability, maintaining logs and closing change control completely.
  • Manage and execute any assigned projects needed to support business growth
    • Create Project Plan and document through the Change Control Process.

Temporary Responsibilities until Duties are reassigned:

  • Sterile Inspection
    • Review documentation from shipping to ensure inspection was conducted and within passing limits. Notify team of passing QA inspection.
  • Manage Deviation Program
    • Responsible for issuance of Deviation Numbers at CT and KY Site.
    • Maintain documentation, provide subject matter expertise and provide approvals.
  • Quality Management Inputs:
    • Participate and provide feedback at the New Product Introduction Committee Meetings.
    • Participate and provide feedback for Product Selection Committee (PSC) and New Products Project Status Meetings (NPI SWAT).
  • Change Control Process
    • Manage and Process Change Controls for New Product Set up, Private label opportunities and new package size.
Skills & Qualifications
  • Education:  BS in science or related field – 3-5 years
  • ISO 9001 and cGMP experience preferred
  • Proficient in Excel and Word
  • Strong communication and interpersonal skills
  • Proven work experience and qualifications as a collaborative and agile team member
  • Strong organization and time-management skills
  • Proven ability to multi-task and pay attention to detail
Qualities
  • Effectively communicates in a team-based environment
  • Can multitask and handles multiple tasks of varying complexity
  • Possesses Company values of honesty, integrity and commitment coupled with the ability to accept change.