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Quality Process Manager

Company: Gaia Herbs
Location: Brevard
Posted on: March 18, 2023

Job Description:

Description:Connecting People, Plants & Planet to Create HealingGaia Herbs takes pride in fostering a collaborative workplace where inspired sessions are the norm, and pitching in to support team success is required. We actively seek out team players who value mission-driven work and love bringing purpose to what we do every day.Gaia Herbs is growing, and as the leading Herbal Supplement company, we feel an ever-increasing responsibility to contribute to a more inclusive and sustainable economy. This is why our status as a Certified B Corporation is so important as we continue building exceptional teams who create great products, all while being great stewards of our farm and our planet.We would love to be your next GREAT employer! Job Summary:The Quality Process Manager (QPM) performs specific quality-related functions within the Quality Control department. The Quality Process Manager is responsible for participating in material reviews, leading corrective and preventive action (CAPA) investigations, and assisting in the change request process. This position oversees the Document Control Manager to ensure the document control process is maintained appropriately. This position will ensure all documents needing updates as a result of investigations/change requests are completed (such as SOPs, TMs, spec sheets, etc.) The Quality Process Manager will manage the Document Control Manager and the Quality Control Project Manager and assist in their processes as required. The Quality Process Manager attends meetings to discuss material reviews, change requests and corrective/preventive actions. Essential Duties and Responsibilities:Participate in material review investigations and trending analysis.Lead CAPAs derived from deviations, out-of-specifications, material reviews and other investigations.Participate in change request follow-ups.Write/Update Standard Operating Procedures (SOPs), Test Methods (TMs), Specification Sheets as needed per investigation follow-ups.Lead meetings to discuss CAPAs due to quality, process-related or operational related matters.Assist in maintaining an up-to-date document control system.Evaluate results of investigations and material reviews.Notify management of quality/compliance trends. Mentor co-workers with developing CAPA investigations.Perform and analyze monthly trending reports of key quality indicators.Conduct material reviews, CAPA investigations and make disposition decisions, when applicable.Review and approve material reviews, when applicable.Audit Master Manufacturing Records (MMRs), SOPs, TMs, and Specification Sheets, to ensure they meet requirements of CAPA investigation.Periodically audit to ensure CAPA improvements have been made and are successful.Review all monitoring of production and process control systems.Supervisory Responsibilities:This position directly supervises the Document Control Specialist and the Quality Control PM.PM20Requirements:Qualifications:The Quality Process Manager must have a deep understanding of the concepts and documents pertaining to a core Good Manufacturing Practices (GMP) Quality Management System: MMRs, batch records, specifications, material reviews, deviations, CAPA, procedures, and policies. The Quality Process Manager is expected to be a competent problem-solver, addressing many small issues, changes, or problems independently, but able to lead a team and delegate when appropriate.Education and/or Experience:Bachelor's degree 3+ years working in a manufacturing setting, or in a QA/QC lab.Experience working in a GMP-regulated industry preferred.Project Management experience preferred.Supervisory experience required.Knowledge, Skills and Abilities:Excellent attention to detail and organization skillsVery strong math and statistical skillsProfessional level oral and written communication skills.Proficient with spreadsheet applications, such as Microsoft Excel and Smartsheets. Ability to learn new computer systems, search for information, and input data.Physical DemandsReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand and walk. The employee is regularly required to sit; use hands to handle, or feel; and reach with hands and arms, and occasionally lift up to 40 pounds. The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl, talk or hear; and taste or smell. Specific vision abilities required by this job include the ability to view a computer screen.Work EnvironmentThis position will work regularly at a desk and computer, reviewing documents and accessing databases, logs, and scanned records. Frequently, this position will be required to walk to the manufacturing area to gather information or explanations from individuals - which will require wearing a lab coat, hair net, and/or beard net (as applicable).Our Perks & Benefits:Medical, Dental, and Vision insurance - eligible the first day of the month after you start. Health savings accountWellness discounts on health insurancePTO, sick leave, paid holidays401(k) - 100% match up to 3%Annual Incentive Plan (Bonus)Stock OptionsVolunteer time offVoting time offRecognition programsGaia product discountsBirthday honey from the Gaian beesGaia swagNutritious lunches cooked by our own company chef using Gaia's herbs, veggies and local organic meats. Free farmer's market during season from Gaia's own 350-acre farm. Equal Employment Opportunity has been, and will continue to be, a fundamental principle at Gaia Herbs, Inc., where employment is based upon personal capabilities and qualifications without discrimination based on race, color, religion, gender or gender identity, age, national origin, sexual orientation, physical or mental disability, veteran status, or any other protected characteristic as established by law. All employees and applicants will be treated fairly, with dignity and respect, in accordance with, and as defined by federal, state and local non-discrimination laws.PI206671546

Keywords: Gaia Herbs, Asheville , Quality Process Manager, Executive , Brevard, North Carolina

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