Natural Products GMP & Production Compliance Director

B Corp: 

Location: 

Portland, OR

Job Type: 

Full Time

Category: 

Executive

Required Education Level: 

Bachelor's Degree

Job Title: Natural Products GMP & Production Compliance Director


Job Description:

American College of Healthcare Sciences has been educating industry leading holistic health professionals since 1978. A worldwide innovator in online integrative health education, ACHS is accredited by the Distance Education Accrediting Commission (DEAC). ACHS specializes in accredited online graduate and undergraduate degrees, diplomas, certificates, and continuing education courses in integrative health and wellness fields like aromatherapy, herbal medicine, and more.

Our mission is to provide leadership in holistic health education through comprehensive professional online and on-campus education and high-quality natural products with a commitment to sustainable practices and principles.

As a Certified B Corporation, ACHS is devoted to excellence in education, sustainability, and ethical business practices. For more information, visit www.achs.edu.

ACHS is a When Work Works award winner for 2016; Oregonian Top 100 Workplaces award winner 2016 and 2017; #6 on Oregon Business Magazine’s Top Green Workplaces 2016 and #6 on Oregon Business Magazine’s Top 100 Workplaces 2017; 2016 BBB Business of the Year Torch Award for Ethics Finalist; 2017 Military Friendly school for the 8th consecutive year; and #7 most affordable online nutrition degree by OnlineU.

ACHS is currently seeking a Production Compliance Director to join its team. Must be available to work on-site in the Hood Avenue Portland campus Monday to Friday, 8:30 am to 5:30 pm. ACHS seeks a candidate who is precise and methodical, with an excellent attention to detail and demonstrated work ethic.

 

Responsibilities:

Reporting to the Executive Management team, provides strategic leadership in the development, management, and implementation of the institution’s Good Manufacturing Practices program.

Reporting to the Chief Compliance Officer, manages ongoing compliance efforts and keeps current with changes in FDA requirements and FTC enforcement, and liaises with the FDA as needed.

Manages the production, labeling, and compliance of all ACHS packaged herbs, oils, and other natural products.

Manages the production, labeling, and compliance of all ACHS proprietary essential oil blends including production of the Product Formulation Sheet, compliant product labeling, and submission to Oregon Tilth for approval.

Analyzes and reviews current practices to assure that they align with GMP requirements. Identifies deficits and makes recommendations to ensure compliant practices

Drafts necessary GMP policies, procedures, records, forms, and specifications for dietary supplement products. Reviews and revises current procedures and policies in order to align with GMP requirements.

Provides ongoing GMP and quality training to production staff; provides ongoing FDA and FTC training to retail staff. Able to provide basic GMP training to ACHS students and graduates in face to face and online webinar formats.

Reviews GMP regulation updates and keeps current on enforcement trends.

Conducts routine checks on production practices and record keeping to assure GMP compliance. 

Familiar with the Dietary Supplement Health and Education Act (DSHEA) and ensure compliance with the requirements for making structure-function claims about products.

Regularly analyzes and reviews labels and marketing material, including email promotions and AShoppe descriptions to ensure that content is FDA and FTC compliant.

Manages Oregon Tilth compliance, including but not limited to:  ensuring vendor certificates are up to date at the time of purchase and receipt of product, submitting all new organic product requests, maintaining compliant organic files (must have experience with international vendors and organic certifiers).

Maintains all records and production procedures in line with Oregon Tilth standards and keeps ACHS’s Organic Handling Procedures accurate and up-to-date. 

Responsible for the production of all product labels, assuring compliance with Oregon Tilth and GMP requirements.

Researches and potentially implements a variety of marketing certifications for natural products, eg, fair trade cert, salmon-friendly cert, non-gmo cert.

Assists with customer inquiries related to products and processing.

Monitors California’s Prop 65 and other related state regulations in order to keep practices current and compliant.

 

Requirements:

Bachelor's degree (or higher) in Quality Assurance, Regulatory Compliance, or similar

Two or more years experience managing Oregon Tilth and GMP compliance

Thorough knowledge of Oregon Tilth’s organic certification program

Thorough knowledge of FDA’s GMPs for Dietary Supplements

Knowledge of and experience with assuring DSHEA compliance

Demonstrated excellent interpersonal and communication skills

Experience with group presentations on compliance-related topics

Experience with managing multiple tasks using project management software

Able to aptly juggle competing priorities

Strong Apple Mac skills and expertise in MS Word, Excel, PowerPoint, Google Docs etc

Strong writing, editing, and proofreading skills

Creative problem solver with a willingness to ask questions to ensure compliance

Ability to prioritize, schedule, and calmly meet tight deadlines

Works well both independently and within a team

Ability to work effectively in a fast-paced, dynamic environment

Interest, knowledge, and/or experience in holistic health preferred

 

ACHS Offers:

Benefits include subsidized medical, dental and vision coverage; paid vacation, holidays, and sick leave; employer-provided short- and long-term disability and life insurance, additional voluntary life insurance also available; paid parental leave; subsidized childcare; tax-deferred flex spending and dependent care options; 401K; education credits; subsidized gym membership; and the satisfaction of making a difference in the lives of each and everyone of our students and graduates.

ACHS is committed to equal opportunity and equal treatment for all qualified individuals and supports workforce diversity. ACHS does not discriminate nor will it tolerate discrimination against any person because of age, gender, gender-identity, color, race, national origin, religion, sex, sexual orientation, marital status, disability, veteran status, or any other class protected by law.

ACHS complies with Title IX of the Education Amendments of 1972, a federal law that prohibits sex discrimination in education, including but not limited to all forms of sexual harassment and sexual violence. Any person who files a complaint or participates in an investigation is protected from retaliation to the full extent of the law. Questions regarding Title IX may be referred to ACHS’s Title IX Coordinator: Lisa Easler, HR Manager & GMP Compliance Director, lisaeasler@achs.edu, 503-244-0726; and/or to the U.S. Department of Education’s Office for Civil Rights.

To Apply:

Our online application will give you the option to apply to this role as a complete candidate – not just a resume. The application will assess your qualifications, personality traits and workplace preferences, and should take 10 to 15 minutes to complete. After submitting you'll receive an email allowing you to log in and view your assessment results and application.

We value diversity and inclusion and encourage all qualified people to apply. If you require any accommodation in the recruitment process, please contact us with the “Need Help” button in the application.

Please apply here: https://www.fitzii.com/apply/15524?s=bc