Work for a leader in the formulation, manufacture, and distribution of natural vitamins and nutritional supplements!  Its product line includes amino acids; digestive enzymes; herbal products, such as organic black teas, white and green teas, and herbal extracts; personal care and beauty products, such as facial, oral, hair, and body care products; sports and fitness nutrition products; performance nutrition products; and various nutritional supplements. The company offers its products through health food stores in the United States and distributes worldwide

Position Summary: Ensures compliance with all US and International Quality requirements including participation in all agency audits. The QA Manager oversees all Quality Assurance functions.

Responsible for the inspection of all raw materials, work-in-process (packaging and manufacturing) blends, liquids, purchased and manufactured finished products.Responsible for the Label Room and Return functions. Responsible for the compilation and review of all batch records, test data, inspection reports, vendor’s certificates and calibration program.

Position Scope:

• Manages Quality Assurance Supervisor, QA Inspectors (including Leads), Label Room Attendant, Document Control Personnel, and Quality Return Clerk @ Distribution Center and other Quality Assurance personnel as assigned.

Position Responsibility:

• Enforces the Standard Operating Procedures (SOP’s) that are applicable to the Facility, Production (Manufacturing and Packaging) and Distribution.

   

• Reviews, edits, and drafts department SOPs to ensure continued compliance with applicable regulations.

   

• Assists with all audits as needed (FDA, NSF, etc.)

   

• In conjunction with other departments, performs audits of new suppliers.

   

• In conjunction with other departments, performs internal audits.

   

• In conjunction with other departments, performs mock recalls.

   

• Responsible for halting a process once it is found to be a deviation of the SOP. Issues deviations in accordance with the SOP’s.Issues material status notices, deviation and investigation numbers to ensure control of all non-conforming material.Tracks the deviation to ensure proper completion of relevant documentation prior to release of product.Summarizes and trends the deviations consistent with cGMP requirements.

• Ensures that appropriate documentation is present in the file as required, e.g. deviations, investigation/hold reports.

   

• Reviews all deviation and inspection reports.

   

• Coordinates and manages with Quality Control to ensure raw materials, bulk goods and finished products are released in a timely manner to ensure service level.

   

• Communicates, orally and written, with other departments both internally and externally to provide status updates, e.g., Purchasing, Distribution.

   

• Communicates with the Purchasing department and outside vendors to obtain paperwork needed for product release.

   

• Provides technical assistance as necessary to ensure that products meet all required specifications.

   

• Attends inventory planning meetings to advise Production regarding status of materials and to obtain production requirements for ensuing time period.

   

• Evaluates activities within release area and makes recommendations to improve and streamline process.

   

• Reviews, edits, and drafts department SOPs to ensure continued compliance with applicable regulations.

   

• Trains additional personnel in tasks and duties in the release area and to ensure coverage as necessary.

• Human Resource functions to include subordinate performance reviews, recommending promotions, issuing disciplinary warnings, time clock administration, as well as work shift assignment scheduling.

   

• Maintains professional and technical knowledge by attending educational symposia; reviewing professional publications; establishing personal networks; participating in professional societies, etc.

   

  • Assures compliance by following Food and Drug Administration's Good Manufacturing Practices as well as other regulatory standards as required by the department.

     

• Performs periodic audits of existing vendors.

   

• The above is not intended to be an all-inclusive list of responsibilities.Other activities may be assigned as required by management.

QUALIFICATIONS

Experience and Skills:

• 10 years prior experience in a Quality Assurance Department in the area of pharmaceuticals, nutraceuticals or Natural Products including 5 years of prior Supervisory/Managerial experience.
• Must have strong problem-solving skills and be able to assist the team when quality issues arise.
• Demonstrated leadership abilities and good interpersonal skills
• Demonstrated ability to work well on cross-functional teams with project management skills.
• Proven strong written and oral skills, together with strong organizational and management skills are a must.
• Ability to be self-motivated as well as work in a team environment
• Ability to train employees, both inter- and intra-departmentally
• Good attention to detail
• Strong competence in office software applications including Excel, Word, Outlook (Power Point a plus) and mainframe experience.
• Work OT and Saturdays as needed.

Education and Certifications:

• Bachelor’s degree, preferably in management or science or in a food and supplement related field