Associate Regulatory Compliance Specialist

Job Title: Associate Regulatory Compliance Specialist

Department: Quality

Business Unit: Herb Pharm

Reports To: Director of Quality

Location: Williams and Central Point

Job Type: Full-Time

FLSA Status: Exempt

Pay Range: $54,000 - $58,000 annually

At-Will Employment

Herb Pharm is an ‘At-Will’ employer. Nothing in this job description should be interpreted as an employment contract.

Job Summary

This position provides support to the Quality department in maintaining regulatory compliance programs, document control systems, and customer complaint processes. The role provides administrative and coordination support for regulatory activities while developing knowledge of applicable regulatory requirements and quality systems. The ideal candidate must be detail oriented, organized, and interested in building a career in regulatory affairs and quality compliance. Additionally, they must be able to perform work in a timely and accurate manner and maintain confidentiality with proprietary and sensitive documents and information. They should have the ability to prioritize, manage time well, multitask and troubleshoot. Strong interpersonal and interdepartmental communication and customer service skills are essential. Experience with regulatory compliance of customer complaint systems, controlled documents, and manufacturing of consumer product goods is preferred.

Supervisory Responsibilities

None

Key Performance Indicators (KPIs)

• Maintain complaint records with accuracy and completeness.

• documents meet internal turnaround time standards.

• Ensure serious adverse event MedWatch reports are filed to meet all FDA requirements.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Oversee and implement the product complaint system including packaging and herbal complaints, adverse events, and serious adverse events.

• Ensure regulatory compliance with the complaint system including accurate documentation of complaint status, investigations under the direction of the Quality management team. Assist with the preparation of regulatory documentation, including the filing of MedWatch documentation for serious adverse events.

• Prepare and organize structure function documentation for review and submission to FDA portal.

• Support maintenance of distributor compliance portals including submission of required documentation, resolution of action items, and necessary follow-up to support the Sales department goals.

• Assist with B Corp certification process when applicable.

• Support the Document Control program.

• Coordinate the creation of logs, forms, and documents into appropriate templates.

• Coordinate the publication of documents to appropriate channels.

• Support and coordinate the implementation and maintenance of document control master table of contents list. Including version control, revision history, control numbers, and document status (active/inactive/archived).

• Coordinate document requests and maintain document control records.

• Learn applicable FDA, GMP, and internal quality requirements.

• Assist with regulatory audits and inspections by gathering requested documentation.

• Maintain regulatory and quality records in accordance with company procedures.

• Participate in departmental training and continuous improvement activities.

• Support special projects assigned by the Quality Department.

• Maintain a working knowledge of relevant government and industry quality assurance standards, codes, and regulations.

• Maintain a safe work environment through adherence to companywide safety protocols.

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Required Education and Experience

Education: Bachelor’s degree in related field.

Associate degree with relevant internship or work experience may be considered.

Experience: Minimum 2 years of experience or training in quality management systems or laboratory setting as it pertains to consumer product goods.

Experience with document control systems in a regulated industry preferred.

Equivalent combination of education and experience will be considered.

Required Qualifications

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, botanical guides, plant identification manuals, and governmental regulations.

Ability to write reports, business correspondence, and procedure manuals.

Ability to effectively present information and respond to questions from groups of managers. Strong attention to detail, with solid knowledge of grammar and punctuation, ability to proofread accurately and consistently.

Proficient in MS Office Suites

Preferred Qualifications

These are not required but are ideal for a successful candidate:

• Knowledge of current Good Manufacturing Practice as it pertains to 21 CFR Part 117 and 111.

• Knowledge of the USDA National Organic Program and 7 CFR 205 as it pertains to dietary supplement manufacturing.

• Experience working within a product complaint system as it pertains to consumer product goods.

Working Conditions

• Work Environment: On-site office and on-site manufacturing environment

• Travel Requirements: None

• Physical Demands: Primarily desk work with up to 25% in a GMP manufacturing environment.