Job description

28-32 hours/week Mon. - Thurs. This is an hourly position with benefits that include paid time off, a generous product stipend and a beautiful, unique work environment.

Avena Botanicals is a small artisan business in mid-coast Maine providing high quality, handmade herbal products from seed to bottle. We are an herbal apothecary that has offered a variety of hand-crafted herbal remedies for the past 30 years. Most of our products are made with herbs grown and hand-harvested from our own biodynamic, organic gardens in Rockport, Maine.

Do you have a manufacturing background and a desire to experience an alternative work environment? If so, you might be just the person we are looking for to join our collaborative team in the role of Quality Assurance Coordinator.

The Quality Assurance Coordinator is responsible for ensuring that all company processes meet quality standards, from raw ingredient receiving to finished product. Initially the person in this role will work extensively with a regulatory consultant to rework our quality assurance programs and policies and thereafter will be responsible for maintaining said programs. The focus of this position is on maintaining adherence to Current Good Manufacturing Practices (cGMPs) as outlined in FDA CFR Title 21, Part 111. The qualified candidate would preferably be someone who has worked in a cGMP botanical or food manufacturing company and has assisted in the development of programs and documentation related to Quality Assurance.

Quality Assurance Primary Responsibilities:

• Serve as primary liaison to regulatory consultants.
• Maintain compliance with all relevant regulatory agencies.
• Establish, monitor and maintain quality assurance policies and procedures.
• Monitor and maintain product quality through inspection, testing and documentation.
• Establish and maintain document control program.
• Identify training needs and organize training programs to assist staff in meeting quality standards.
• Serve as the company representative and escort during FDA audits.
• Enhance job knowledge by studying trends and developments in quality management, participating in educational opportunities, reading professional publications, and networking with other companies within the herbal community.
• Communicate the status of compliance and quality assurance projects to the company Founder.

Required Knowledge, Skills and Abilities:

• Have experience implementing or maintaining a Quality Management System or relevant experience with a cGMP and FDA audited environment.
• Bachelor’s degree in a scientific field preferred, or equivalent combination of experience and training that provides the required knowledge, skills, and abilities.
• Be comfortable serving as the company representative during regulatory audits.
• Have strong computer skills including Microsoft Office.
• Be able to work independently and as part of a team.
• Extremely detail oriented with good organizational skills.
• Good communication skills – both verbal and written.
• Supervisory and/or leadership skills.
• Have a positive attitude.
• Independent judgment is needed to plan, prioritize and organize a diversified workload.
• Some herbal experience is preferable, but an openness and interest is most important.

Compensation

this position is:

Application instructions

Deadline

no deadline