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Quality Assurance Coordinator in Nashville at Vaco

Date Posted: 2/14/2018

Job Snapshot

Job Description

Vaco is working with a client in Nashville, TN looking for a Quality Assurance Coordinator. You will be responsible to increase customer satisfaction and effectively manage risk to the business by developing, implementing and monitoring a robust quality assurance program to maintain compliance with applicable regulations and guidance documents.

You will support the company's short and long-term goals for maintaining compliance with respect to own label distributors, suppliers, contract manufacturers, quality management systems and associated quality agreements.

This position is the cornerstone of the company's quality management system team and one of the key drivers in insuring suppliers' compliance with the company's quality expectations and driving continuous improvement related to industry and government driven regulatory revisions and updates.

This role requires a high level of precision and attention to detail along with persistence and a desire to see projects through to completion. It also requires a commitment to building and maintaining relationships, both with other departments within the company and with external partners and vendors.

You will become the first point of contact with contract manufacturing partners for quality assurance issues. You will help identify and solve problems as well as bring them up to speed on the latest trends and developments according to our company's quality initiatives, becoming their "go to" person for any and all compliance questions and answers.

  • Organize and promote quality and compliance improvement efforts for contract manufacturing, including but not limited to FDA Dietary Supplement guidelines (21 CFR 111) as well as current implemented regulatory requirements (Foreign Supplier Verification Program).
  • Assist with writing and editing SOP's and associated forms that match the practiced process and meet compliance guidelines.
  • Assist with establishing and reviewing associated Quality Agreements between the company, third party manufacturers and suppliers.
  • Assist in developing product specifications to determine present scientifically validated standards and establish proposed quality and reliability of the finished products.
  • Work with managers and teams to assess and ensure compliance with cGMP and company compliance plan against internal (policy/procedure) and external (contract/program) requirements and report regularly on the results.
  • Work in partnership with the Supply Chain team, Marketing and Product Development to solve problems and provide expertise on compliance issues as it relates to contract manufacturing products.
  • Identify inadequacies in documentation associated with contract manufactured products in order to avoid costly product recalls, withdrawals and regulatory actions.
  • Proactively lead quality system enhancement projects to decrease the likelihood of action resulting from a regulatory action.
  • Respond to, research and provide corrective actions to customer complaints regarding quality.
  • Assist in establishing, monitoring and revising product specifications and lab testing reports.
  • Manage Documentation processes, including, but not limited to the following to meet regulatory requirements:
    • Standard Operating Procedures, specifications and forms
    • Label review/release
    • Batch record review/release
    • Master Batch record review/approval
    • Protocol review/approval
    • Deviation review/approval
    • Change Control review/approval
    • Corrective Action Preventive Action Program
  • Assist with planning, organizing and supporting a comprehensive vendor management program, which includes auditing the vendors
  • Actively participate in Dietary Supplement and cGMP inspections and audits including required responses, follow up and corrective action documentation and implementation
  • Review analytical testing and data analysis in accordance with procedures
  • Review contract manufacturer MMRs and BPRs
  • Act as one of three people who sign MMR's into effectiveness
  • Act as one of three people who sign SOP's info effectiveness
  • You will check for accuracy of copy and issue batch records as needed