What are the responsibilities and job description for the Quality Systems & Regulatory Specialist position at THE VISUAL PAK COMPANIES?
Job Details
Description
Join the PAK
The Visual Pak Companies are aligned with many of the largest consumer product companies in the household, personal care, automotive and food product industries.
30 years of consistent growth with no end in sight is a testament to our best-in-class workforce as the foundation for our collective success. The Visual Pak is looking for innovative and dedicated achievers who are encouraged to keep a healthy work/life balance to join our team.
Quality Systems & Regulatory Specialist
The Quality System & Regulatory Specialist is responsible for overseeing, implementing, and maintaining the organization’s compliance with ISO 9001, ISO 22716, and FDA OTC regulatory requirements within a contract manufacturing environment. This role ensures the development and ongoing maintenance of a robust Quality Management System (QMS), aligning operations with international standards and regulatory frameworks. The Specialist serves as a key advocate for quality and compliance, driving continuous improvement and fostering a culture of excellence across the organization.
Direct Reports
None
Position Responsibilities-Tasks-Deliverables
An individual must be able to satisfactorily perform each essential duty listed below. The requirements listed are representative of the knowledge, skills, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform these essential functions.
All duties as assigned and the following specific activities.
1. Quality Management System (QMS) Implementation and Maintenance:
- Develop, implement, and manage the enterprise QMS to ensure compliance with ISO 9001, ISO 22716, and FDA OTC regulations.
- Regularly review and update policies, procedures, and work instructions to reflect current standards and regulatory requirements.
- Collaborate with cross-functional teams throughout the VP enterprise to ensure QMS integration into daily operations to align quality initiatives with business objectives.
2. Regulatory Compliance:
- Ensure full compliance with FDA OTC regulations, including Good Manufacturing Practices (GMP).
- Along with site leadership, act as the primary liaison during regulatory inspections, ISO certification audits, and other external assessments.
- Monitor regulatory changes and implement updates to maintain compliance with evolving standards.
3. Certification Management:
- Lead the implementation and certification processes for ISO 9001 and ISO 22716, including initial certification, audits, and renewals.
- Coordinate and manage internal and external audits to ensure ongoing compliance with ISO standards and FDA regulations.
4. Continuous Improvement & Risk Management:
- Conduct internal audits and assessments to identify gaps, risks, and opportunities for improvement.
- Utilize quality tools (e.g., FMEA, risk assessments) to enhance operational processes and minimize risks.
5. Training & Quality Culture:
- Develop and deliver training programs for employees on ISO standards, FDA OTC regulations, GMP, and QMS requirements.
- Promote a culture of quality, compliance, and continuous improvement across all Visual Pak sites and departments.
- Serve as a resource for employees on regulatory and quality-related inquiries.
6. Documentation & Reporting:
- Maintain accurate and organized documentation related to the QMS, ISO certifications, and regulatory compliance.
- Oversee document control systems to ensure compliance with ISO and FDA requirements.
Key Performance Indicators (KPIs)
On-going outcome that is measurable
- Maintain ISO 9001 22716 Certification
- Maintain FDA Certification
- Up to date on all Internal audits
- Employees are up to date with training.
Benefits:
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life & AD&D Insurance
- 401(k)
- 401(k) match
- Pet Insurance
- Paid time-off
- Paid holidays
- Tuition reimbursement
- Flexible Spending Account
- Dependent Care Subsidy
- Childcare Resources
- Commuter Benefits
- Employee Assistance Program
- Disability Insurance
- Employee Discounts
Qualifications
Knowledge-Skills-Abilities
Education:
- Preferred Bachelor’s degree in Quality Management, Regulatory Affairs, Engineering, Life Sciences, or a related field.
Experience:
- 3–5 years of experience in quality systems, regulatory compliance, ISO certifications, and FDA OTC regulations in a manufacturing environment.
- ISO 9001 and ISO 22716 Lead Auditor certification preferred.
- Hands-on experience with FDA inspections, GMP practices, and regulatory submissions is a strong advantage.
Technology/Software (years):
- Must be proficient in Microsoft office.
Communication:
- Excellent communication skills (both verbal and written), to communicate with all personnel.
Skills & Competencies:
- Deep knowledge of ISO 9001, ISO 22716, FDA OTC regulations, and GMP requirements.
- Strong project management and organizational skills, with the ability to handle multiple priorities.
- Exceptional problem-solving and analytical skills, including root cause analysis and CAPA implementation.
- Excellent written and verbal communication skills for writing procedures, reporting, training, and collaboration.
- Proficiency in quality management tools and software (e.g., CAPA systems, FMEA, risk assessments).
Physical Capabilities (add lines as needed)
Strength (lifting, dexterity, repetitive motion):
Movement (standing, stopping, sitting, crouching, crawling):
Hearing (loud noise tolerance, quiet work area, public speaking, receive work direction):
Vision (judge distance, read signs, extended computer work, identify details):
MISCELLANEOUS
Travel: Driving from liquid facility to liquid facility
Vehicle (own): Use own vehicle
Tools (own):
Technology (own)
Visual Pak Companies is an Equal Opportunity Employer. Visual Pak does not discriminate on the basis of race, color, religion, marital status, age, national origin, disability, medical condition, pregnancy, gender (orientation or identification), sexual orientation, veteran status, or any other basis covered by federal, state, or local laws. All employment decisions are based on qualifications, merit, skills, individual performance, and business needs.
Salary : $70,293 - $105,439
