QA Document Control (Nutraceuticals)

Marlyn Nutraceuticals is a solution-focused, privately held nutraceutical company formulating, developing, and manufacturing science-based, natural dietary supplement formulas since our humble beginnings in 1948.

Our specialties are innovative, high-quality, and cost-effective natural remedies for everyday health issues such as immune system support.

We are currently looking for a Quality Assurance Document Control team member who will be responsible for manufacturing plant quality assurance functions, including product batch record review and release, non-conformance issues, internal audits, consumer complaints, and development of acceptable quality levels for inspection of finished goods and packaging components.

This position will report to Marlyn's QA Manager.

Detailed Duties & Responsibilities :

• Review and approve master manufacturing records, planned deviations, change requests and product releases.
• Maintain and update, as required, acceptable finished product and packaging inspectional standards to assure product quality.
• Issue material review for product that fails to meet the established quality levels and assure that the root cause of the problem is identified, and appropriate corrective actions are implemented to prevent re-occurrence of the failure.
• Develop and maintain tracking / trending reports to allow Management to gain the appropriate visibility on product quality.
• Ensure that all procedures and activities performed are GMP (Good Manufacturing Practice) compliant.
• Manage the CAPA (Corrective Action, Preventive Action) program.
• Review and respond to all complaint and non-conformance requests.
• Manage document control and compliance.
• Conduct internal audits for compliance to 21CFR Part 111.

Skills Required :

Experience Required :

Education Required :