Director of Quality

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Job Description: 

The Herb Pharm name has become synonymous with quality, driven by years of pioneering industry excellence in all aspects of manufacturing and customer service. 

We are currently seeking a Director of Quality to join our team in Williams, Oregon.

The Director of Quality upholds this commitment and develops, implements, oversees, and evaluates the organization's Quality Department and Quality Assurance and Quality Control (QAQC) program. 

In so doing, the Quality Department ensures that the highest operational standards are met, from raw materials to finished goods. The following duties are performed in collaboration with Botanical Affairs and the Operations teams, thereby contributing to the organization's overall successful operation and growth. 

Essential Duties & Responsibilities include the following, other duties may be assigned: 

  • Leads the Quality Department across Herb Pharm, Pacific Botanicals and Mushroom Harvest.
  • Establishes quality and reliability standards that meet and exceed industry best-practice and all regulatory requirements.
  • Ensures the identity, purity, strength, composition, and limits on contamination of raw material, in-process, and finished goods.
  • Implements inspection standards by studying manufacturing methods and devising testing methods and procedures.
  • Responsible for identifying opportunities, in partnership with internal partners and industry associations (e.g. AHPA), to improve departmental processes and procedures to increase quality, efficiency, and effectiveness.
  • Provides regulatory support to Quality, Sales, Customer Service and Marketing departments.
  • Supports and holds the Operations department accountable to ensure herbal ingredient, extraction, and processing standards.
  • Collaborates with Marketing and Quality to ensure proper labeling of products.
  • Creates product quality documentation system by writing and updating quality assurance procedures such as checklists, logs, and reports for effectiveness, accuracy, and relevance.
  • Supports Operations and Engineering in new process development and significant process change.
  • Assesses test results and approves recommended changes.
  • Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
  • Oversees mock recalls, recalls, and withdrawals, including forward and backward traceability of raw materials and finished goods, respectively.
  • Oversees scheduled/random internal and external audits and quality control checks.
  • Oversees Corrective Action Preventive Action (CAPA) policy and procedures including root cause analysis.
  • Oversees complaint records and classifications including adverse and serious adverse events.
  • Periodically reports quality control and operations status to stakeholders, and, when required, regulatory agencies.
  • Performs qualification and audits of contract manufacturers and third-party laboratories.
  • Conducts performance evaluations that are timely and constructive.
  • Trains, coaches, and counsels Quality employees in accordance with company policy.
  • Achieves financial objectives by preparing the Quality budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
  • Assists with efficient team operation and continuous process improvement, by participating actively in all team and departmental meetings as requested.
  • Regularly leads and/or assists with special projects as directed.

Education and Experience:

  • Bachelor’s degree (BS) in Food Science, Microbiology,
  • Engineering, or a related field is required; a Master's degree or higher is strongly preferred
  • Five+ years related experience and/or training, or equivalent combination of education and experience. 
  • Minimum five years of experience in a consumer-packaged goods manufacturing environment.
  • Minimum five years of experience implementing an ISO 9001 Quality
  • Management System or equivalent.
  • Minimum two years’ experience leading quality audits.
  • Experience with QA measuring and testing equipment.
  • Technical Requirements:
  • Proficiency in Office365.
  • Expertise in database management, presentation development, and word processing software.

Qualifications & Requirements:

  • Expert knowledge of 21 CFR Part 11, 111, and 117 and 7 CFR 205 as it pertains to a dietary supplement manufacturing environment.
  • Knowledge of ISO 17025 certification requirements and ISO 17043 proficiency testing preferred.
  • Knowledge of IQ/OQ/PQ policy and procedures in an FDA-regulated facility preferred.
  • Demonstrated history of cross-department collaboration on continuous improvement projects.
  • Effective problem-solving skills with the ability to diagnose quality issues and develop functional solutions.
  • Maintains professional and technical knowledge by attending botanical, herbal, and dietary supplement trade organization committee meetings and educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
  • Knowledge of validated and accredited analytical methods as it pertains to the following:

    • Limit of quantification (LOQ)
    • Limit of detection (LOD)
    • Measure of Uncertainty (MOU)
    • Relative standard deviation (%RSD)
    • Method repeatability
    • Method reproducibility
    • Instrumentation control charting and system suitability reports
  • Ability to work in a fast-paced environment and manage multiple cross-departmental projects to completion.
  • Well organized, with the ability to set priorities and meet reasonable deadlines.

Location: Position covers all Herb Pharm Facilities - Pacific Botanicals in Grants Pass, Herb Pharm Headquarters in Williams, Herb Pharm Operations in Central Point & Mushroom Harvest in Sequim, WA Ability to travel to all local Oregon sites on a weekly basis, to Mushroom Harvest site on a quarterly basis, and to industry conferences and training in the United States approximately 4 times per year for up to a week at a time. Responsible for independent travel arrangements.

Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to articulate and present ideas and solutions effectively to leadership, vendors, team members, and the public. Strong written and verbal communication skills, including the ability to develop employee manuals and communicate across departments.

Reasoning Skills: Ability to solve practical problems and deal with a variety of situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Interpersonal Skills: Strong leadership skills, including the ability to quickly organize and communicate thoughts and to understand communications from others. The ability to maintain composure and professionalism, as well as to listen and respond appropriately.

Physical Requirements: Prolonged periods sitting or standing at a desk and working on a computer.

At-Will Employment: Herb Pharm is an ‘At-Will’ employer. Nothing in this job description should be interpreted as an employment contract. Job responsibilities and tasks may be modified from time to time based on the company's needs.

Compensation range: $145,000/year DOE

Our company is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression, or any other basis protected by local, state or federal law.

This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.

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