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:

• Practical understanding and implementation of applicable GMPs (as they pertain to 21CFR Part 110 and 111).
• Experience in a Quality Department located within a manufacturing plant environment.
• Prior management of Quality department within a manufacturing environment preferred.
• Experience in application of dietary supplement/pharmaceutical GMPs.
• Experience in a quality department within a regulated manufacturing plant
• Experience managing a Quality department within a dietary supplement/ pharmaceutical manufacturing environment.

Experience Required:

• Minimum of 5 years' experience in a government regulated industry.
• Minimum of 5 years' experience in a quality department within a manufacturing industry.
• Minimum of 3 years' experience managing a quality department within a manufacturing environment.

Education Required:

• Bachelor's degree in chemistry
• BS or MS degree in a related science discipline preferred
• ASQ Certified Manager preferred

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Marlyn Nutraceuticals, Inc.
Since 1948, Marlyn Nutraceuticals has been improving consumers' quality of life and enhancing wellness with our natural-based, clean label dietary supplement formulas, available and sold at most major US drug and mass-market store chains. Together with Marlyn's green manufacturing philosophy, which guides every decision and accomplishment of our team, we are strongly committed to our employees, efficiency, productivity, customers, and the community. In the same manner, we passionately believe in equality for everyone, regardless of age, sex, sexual orientation, race, color, creed, religion, ethnicity, national origin, disability, military or veteran status, or any other legally recognized protected basis under federal, state, or local laws, regulations, or ordinances.

Marlyn offers you not only an opportunity to work for a company that is dedicated to the environment and its people but also offers competitive salaries and comprehensive benefit packages. We offer paid holidays, vacation, and sick time, a 401(k)-retirement plan with company match as well as gift cards and luncheons/parties before major holidays. A wide range of benefit choices includes options for medical, dental, vision, life and AD&D, short and long-term disability insurance plans, legal plans, and pet insurance.

- Health Coverage options which extend to your entire family
- Paid Vacation, Sick & Holiday Pay
- Bus Pass Reimbursement Program
- Product Discounts for you and your family
- Luncheons/Parties & gift cards before major holidays
- Year-End Bonus for all employees based on individual and company performance.
- Fully Air-Conditioned Facility
- Free Coffee & Tea
- Company-Provided Uniforms
- 401(k) with Company Match