GMP Compliance Coordinator
OVERVIEW & JOB SUMMARY
Under direct and general supervision of the Senior Manager of Quality, as a member of the Operations Services & Innovation team, the Good Manufacturing Practices (GMP) Compliance Coordinator is responsible for supporting ISO 22716 implementation, ensuring quality compliance, and adhering to ISO 22716 standards and FDA GMP’s in all Dr. Bronner processes. This position oversees verifying that all processes follow strict regulations to prevent issues. The individual must possess strong verbal and written abilities to coordinate implementation and auditing activities. Must be able to interact well with other managers, coordinators and team leads in a teamwork environment to share important ISO 22716 and GMP-related information and reach all crucial objectives within a given timeframe. Schedules and carries out internal audits. Supports external audits. The GMP Compliance Coordinator participates as an active team member in the Quality sub-department of the Operations Services & Innovation team, providing documentation support to colleagues, company-wide efforts, and special projects as needed.
This position is located at Dr. Bronner’s headquarters in Vista, CA, and will not be a remote position once Covid-19 restrictions are lifted.
Diversity, equity, and inclusion are important values at Dr. Bronner’s. All employees are called to practice acceptance, treat others with dignity and respect, learn from and celebrate each other’s differences, recognize one’s own privilege, root out one’s own and speak up against prejudice, and work to create a healthy and respectful workspace where colleagues feel valued and part of our community.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, you must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The following duties and responsibilities are those considered to be essential but do not represent all job functions that may be required to be performed by this position. Other comparable duties and responsibilities may be assigned as needed.
- Assists the Senior Manager of Quality in implementing ISO 22716 across the business. Supports the development of a comprehensive quality management system and FDA-compliant GMP implementation by writing, editing, and implementing new protocols, procedures, processes, test methods, and sampling plans.
- Supports the ISO 22716 certification process working closely with Operations to ensure the quality management system is effective, continually improving, and all certifications remain in good standing.
- Shadows Operations colleagues as needed to document processes.
- Ensures that records are established and maintained to provide evidence that the Management Systems are being followed and that there are systems in place for identification, storage, protection, retrieval, retention time, and disposition of such records.
- Ensures that quality goals are set for measuring the performance of the Management Systems and that these are regularly reviewed and communicated to all involved colleagues.
- Ensures that the internal audit program is developed, implemented, and maintained to verify conformance with the Management Systems.
- Serves as a lead internal auditor for the company.
- Responsible for monitoring, coordinating, and supporting activities related to audits and compliance programs within the scope of ISO 22716 as well as driving systems improvements with other certifications identified as needed.
- Interfaces with internal & external auditors.
- Schedules and coordinates internal and external ISO audits.
- Prepares documentation for ISO and quality-related audits.
- Works with Document Control & Regulatory Affairs Coordinator to maintain accurate and up-to-date policies, procedures, and processes in conjunction with input from relevant leaders and subject matter experts input.
- Reviews and ensures that all documents meet the ISO 22716 standard.
- Communicates necessary information and coordinates with HR and supervisors to ensure consistent training, communication, and education of all affected employees are in place before documents are implemented.
- Initiates non-conformance reports for systems and compliance events.
- Communicates non-compliance and/or imminent risks to appropriate leader(s).
- Assists in the root cause analysis of nonconformances observed from audits and help implement Corrective & Preventive Action Requests.
- Performs follow-up and verification of completion and closure of Corrective & Preventive Action Requests.
- Maintains accurate and up-to-date policies, procedures, and processes in conjunction with input from relevant leaders and subject matter experts input.
- Other duties as assigned within the job scope.
The incumbent will interact closely with Operations, the Production Administration team, Facilities, Human Resources, Automation, Sales & Customer Service teams, Logistics, and key warehouse workers identified.
Completion of a high school diploma or GED. Two years of progressive experience in a quality assurance role and/or manufacturing environment.
Possession of a bachelor’s degree in Science or Business Management or related field with demonstrated equivalent experience.
Expertise with ISO 22716 & FDA GMP Standards.
Three to four years of progressive experience within a drug facility, quality assurance role, and/or manufacturing environment.
Experience as an Internal Auditor for ISO 22716 & FDA GMP.
Any combination of education and work experience that would be equivalent to the stated minimum requirements would qualify for consideration of this position.
KNOWLEDGE, SKILLS, AND ABILITIES
- Attitude: Confident, positive, enthusiastic, down to earth, flexible, & passionate
- Communication: Excellent, adaptive, creative, and concise verbal and written communicator in meeting spaces as well as over the phone, and e-mail; polite, professional, patient, and diplomatic in navigating inquiries; strong grammar skills. Requires strong interpersonal, communication, and organization skills including a good sense of judgment and the ability to build positive work relationships.
- Confidentiality: Maintain a high degree of confidentiality over all matters in the course of business operations including customer and employee information and demonstrate tact, discretion, exercise good judgment and discretion in handling and disseminating information.
- Critical Thinking: Ability to reason and analyze, to set and adhere to a timeline, accurately and independently, and to solve problems.
- Initiative: Responds promptly to requests, works quickly, accurately, and independently; effectively executes strategies, identify upcoming needs and potential risks; proactively manage tasks, meets challenges with resourcefulness, and present ideas and information in a manner that moves the team forward
- Leadership: Highly motivated and cooperative, takes initiative and responsibility for individual and group work, possesses a strong desire to succeed, accepts feedback from others, works with a spirit of enthusiasm and a sense of urgency.
- Organization: Exceptional proficiency in tracking deliverables, tasks, and project deadlines, juggling competing priorities, and multi-tasking efficiently
- Respect: Consciously learn from and celebrate differences among identities while recognizing commonalities and shared experiences; practice inclusive language and promote acceptance, safety, respect, inclusion, and value of individuals within the workplace, and those with whom you interact on behalf of the organization; become aware of all forms of bias, prejudice, and discrimination, and work to eliminate personal vestiges of racism, homophobia and sexism in thought, action and word; promptly report incidents of bias, prejudice, and bigotry to the Human Resources Department or any member of the Executive Team.
- Teamwork: Exhibits objectivity and openness to others’ views, contributes to building a positive team spirit, is flexible to modifying work style to be effective within the group, able to work within a team environment and independently.
- Technical Proficiency: Advanced knowledge of MS Office (Word, PowerPoint, Excel, VISIO, and Outlook); digital file sharing and project management systems (Google Drive, Dropbox, and SharePoint)
- Ability to manage a diverse and expansive workload efficiently.
- Demonstrated ability to manage cross-departmental projects.
TOOLS AND EQUIPMENT USED
Must be proficient in the operation of standard office support equipment including, but not limited to, personal computer, copier/scanner, fax, telephone system, etc.
ISO 22716 and FDA GMP Standards.
Must have reliable transportation and possess and maintain a valid California driver’s license including proof of personal vehicle insurance coverage and insurability under the Company’s insurance carrier standards.
PHYSICAL, MENTAL AND ENVIRONMENTAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to:
- Perform work in a climate-controlled office setting.
- Sit, stand, walk, bend, kneel, and uses hands, arms and legs for dexterity and balance frequently.
- Occasionally lifts, carries, and balances objects weighing up to 35 pounds.
- Pulls and pushes objects such as file drawers, loaded carts, audio/visual equipment, computers, and similar office equipment and supplies.
- Prioritizes and multi-tasks work and projects requiring good memory, concentration, and analytical thinking.
- Occasionally is required to perform the safe operation of a vehicle, office equipment, and machines, and recognize and abate safety hazards within the workplace.
- Must be able to hear, see including the distinction of colors, read and communicate verbally and in writing frequently with a wide range of people from divergent socioeconomic backgrounds and origins.
- The noise level in the work environment is usually low to moderate (in a plant environment).
Dr. Bronner’s is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.