DOCS Health

QA Regulatory Specialist

DOCS Health • $96K — $128K *
Waukesha, WI 53188In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Science, Chemistry, Biology, Pharmacy, or related field.
  • Minimum of 2 years in compliance, quality assurance, and/or regulatory roles.
  • Experience in developing and maintaining standard operating procedures (SOPs).
  • Working knowledge of Good Manufacturing Practices (GMP).
  • Strong analytical, problem-solving, and organizational skills.

Responsibilities

  • Oversee distribution activities for quality control compliance.
  • Track and address non-conformances and CAPAs.
  • Ensure compliance with regulatory requirements and GMP.
  • Develop and provide training on SOPs.
  • Support quality assurance activities including inspections and sampling.
  • Collaborate with stakeholders on quality and regulatory matters.
  • Assist in product recalls and maintain quality documentation.

Benefits

  • Full Medical, Dental, and Vision benefits along with a Wellness Program.
  • 401(k) Match Retirement Savings Plan.
  • Paid Time Off (PTO), Holiday Pay, and Floating Holidays.
  • Volunteer Time Off (VTO) for community service.
  • Educational Assistance Program for skill development.
  • Full Paid Parental and Adoption Leave.
  • Access to Employee Assistance Program (LifeWorks).
  • Exclusive employee discounts through Patterson Perks Program.
Full Job Description
This position in onsite Monday-Friday out of our Waukesha location.

Position Summary

The QA Regulatory Specialist is responsible for supporting the development, maintenance, and implementation of quality standards, policies, and procedures to help ensure compliance with applicable regulatory requirements and company standards. This position partners with internal and external stakeholders to support quality assurance and regulatory activities related to product distribution and operations.

Essential Functions

  • Oversee and monitor distribution activities for conformance with established quality control standards and procedures, including temperature-controlled areas where applicable.
  • Track, investigate, and support resolution of non-conformances, corrective and preventive actions (CAPAs), deviations, and change controls.
  • Support compliance with applicable regulatory requirements and Good Manufacturing Practices (GMP) related to the distribution and handling of regulated products.
  • Develop, maintain, and provide training on standard operating procedures (SOPs) and help ensure applicable processes are performed in accordance with established procedures.
  • Support product inspection, sampling, and quality assurance activities in accordance with applicable requirements and company procedures.
  • Partner with internal and external quality and regulatory resources on product compliance, quality, and regulatory matters.
  • Investigate and coordinate product recalls, returns, and/or destruction activities in accordance with applicable regulatory requirements and company procedures.
  • Maintain required quality and regulatory documentation, records, and product samples, as applicable.
  • Develop and/or deliver appropriate quality, regulatory, and SOP training and maintain associated training records.
  • Participate in and provide support for regulatory inspections and audits.
  • Collaborate with manufacturers, suppliers, and other business partners regarding regulatory questions, quality concerns, and product information.
  • Identify opportunities for process improvement and support implementation of quality and compliance initiatives.
  • Comply with company and department policies and standards and perform other duties as assigned.


Minimum Qualifications

Education
  • Bachelor's degree in Science, Chemistry, Biology, Pharmacy, or a related field.


Experience

  • Minimum of 2 years of compliance, quality assurance, and/or regulatory experience.
  • Experience developing, maintaining, and implementing standard operating procedures
  • Working knowledge of Good Manufacturing Practices (GMP).


Knowledge, Skills & Abilities

  • Strong analytical and problem-solving skills.
  • Strong attention to detail and organizational skills.
  • Strong written and verbal communication skills with the ability to effectively engage internal and external stakeholders.
  • Knowledge of process improvement tools and techniques.
  • Proficiency with Microsoft Office applications, including Excel, Word, and Outlook.
  • Ability to interpret and apply regulatory requirements, policies, and procedures.
  • Ability to work collaboratively across functions and manage multiple priorities.


Travel

5% travel may be required based on business needs.

What's In It For You:

We provide competitive benefits, unique incentive programs and rewards for our eligible employees:
  • Full Medical, Dental, and Vision benefits and an integrated Wellness Program
  • 401(k) Match Retirement Savings Plan
  • Paid Time Off (PTO)
  • Holiday Pay & Floating Holidays
  • Volunteer Time Off (VTO)
  • Educational Assistance Program
  • Full Paid Parental and Adoption Leave
  • LifeWorks (Employee Assistance Program)
  • Patterson Perks Program


The potential compensation range for this role is below. The final offer amount could exceed this range, based on various factors such as candidate location (geographical labor market), experience, and skills.

$96,500.00 - $128,700.00

About DOCS Health

Dentrust Optimized Care Solutions provide direct and on-location health services through fixed-clinic settings, mobile treatment centers, telemedicine, portable deployment models, emergency response, case management, and a variety of comprehensive health, dental, and specialty care.

DOCS Health Careers

Joining DOCS Health presents an unparalleled opportunity to become part of a leading team of professionals dedicated to healthcare excellence. DOCS Health is renowned for its commitment to innovation, leadership in the medical field, and a culture that actively supports diversity and professional growth.

Explore Job Opportunities

DOCS Health offers a variety of job opportunities that cater to a range of skills and professional interests. Whether one is seeking a position in healthcare administration, patient care, or medical research, DOCS Health provides a platform where career aspirations turn into reality.

Internship Programs

For those at the beginning of their professional journey, DOCS Health’s internship programs offer a robust foundation in the healthcare industry. Interns gain invaluable experience, working alongside seasoned professionals and engaging in projects that enhance their skills and expand their understanding of the medical field.

Employment Benefits

Choosing a career at DOCS Health means access to outstanding benefits. The company is committed to the well-being of its team members, offering comprehensive health benefits, retirement plans, and generous paid time off. Additionally, employees enjoy continuous learning opportunities through professional development and diversity training programs.

Cultivating a Culture of Growth and Innovation

At DOCS Health, fostering a culture of growth and innovation is paramount. The company encourages its team to pursue innovation in every task and project. With a supportive network and access to cutting-edge technology, team members can explore new ideas and approaches, driving forward the standards of healthcare.

Leadership and Development

Leadership development is a cornerstone of DOCS Health’s commitment to its employees. Through targeted training and real-world application, employees enhance their leadership skills, preparing them for advanced roles within the company. This focus on leadership cultivates a team that is ready to meet challenges and excel in their careers.

Networking and Professional Development

Networking opportunities abound at DOCS Health, with numerous events and platforms that connect employees with industry leaders and peers. These interactions are vital for professional growth and innovation, offering insights and opportunities that are integral to career advancement.

Hiring Process

The hiring process at DOCS Health is designed to be transparent and engaging. Candidates can expect a thorough interview process where they can showcase their skills and learn about the company’s values and expectations. Interested candidates should prepare their resume to reflect relevant experience and skills, tailored to the position they are applying for.

Join the DOCS Health Team

Explore the career pages and current job listings to find where skills and interests align with the needs of DOCS Health. Positions are available for those passionate about making a difference in healthcare and eager to join a team that values hard work and creativity.

Stay Connected with DOCS Health Careers

Keep up to date with the latest from DOCS Health by following the careers blog. Gain insights from insiders, learn about new job openings, and get tips for your next interview or networking event.

Job Alert Emails

Personalize your subscription to receive job alerts and the latest news from DOCS Health. Tailored updates will keep potential candidates informed about new opportunities and developments within the company.

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Learn more about DOCS Health
Size
251 employees
Industry
Healthcare
* Ladders Estimates

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