Quality Assurance Specialist III ( GMP/GCP)
TR/080607-1
Posted: 14/01/2026
- $37 - $40 per hour
- United States, Illinois, North Chicago
- Contract
2 Positions - The main difference between the two is the focus:
Quality Assurance Specialist III - GMP/GDP
Onsite – North Chicago, IL
Contract length - Through end of year to start
Hourly Pay Rate: $37-40/hr (individual medical benefits available at a cost)
The Quality Assurance Specialist will be primarily responsible for supporting the Research and Development quality agreement process with a focus on identifying and implementing process improvements. The QA Specialist also assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).
Job Duties:
Quality Assurance Specialist III - GCP
Onsite – North Chicago, IL
Contract length - Through end of year to start
Hourly Pay Rate: $37-40/hr (individual medical benefits available at a cost)
The Quality Assurance Specialist will be primarily responsible for supporting the Research and Development quality agreement process with a focus on identifying and implementing process improvements. The QA Specialist has a thorough understanding of international GCP regulatory standards and will be supporting & developing the clinical quality agreements process.
Responsibilities:
Qualifications:
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
- GMP/GDP (Good Manufacturing Practice/Good Distribution Practice)
- GCP (Good Clinical Practice)
Quality Assurance Specialist III - GMP/GDP
Onsite – North Chicago, IL
Contract length - Through end of year to start
Hourly Pay Rate: $37-40/hr (individual medical benefits available at a cost)
The Quality Assurance Specialist will be primarily responsible for supporting the Research and Development quality agreement process with a focus on identifying and implementing process improvements. The QA Specialist also assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).
Job Duties:
- Lead or participate in technically complex and strategic cross-functional projects, demonstrating the ability to work across various teams.
- Drive or support strategic initiatives aimed at improving compliance with regulatory requirements and standards.
- Take a proactive role in process improvements, which includes the review and update of current supporting processes and procedures to enhance efficiency and effectiveness.
- Achieve a difficult balance of involvement, independence, and objectivity.
Provide support for periodic review of Quality Agreements, ensuring alignment with organizational and regulatory expectations. - Collect, analyze, and report relevant metrics to inform decision-making and track the effectiveness of initiatives.
- Consistently demonstrate our corporate Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality.
- Bachelor’s degree preferable in a physical science, life science, pharmacy, business, engineering or equivalent experience required
- 5-7 years of experience in Quality Assurance / Regulatory Affairs (Pharmaceutical or Medical Device preferred)
- 3-5 years of experience in regulated industry such as pharmaceutical / medical device manufacturing, or analysis of investigational products for these industries
- Minimum of 7 years’ total combined experience of GMP (Good manufacturing practice) / GDP (Good Distribution Practice) required.
- Must have strong knowledge of vendor selection/oversight & development of technical quality agreements.
- Must have experience with GMP quality agreements and knowledge of worldwide regulatory requirements that influence their content.
- Must have strong proj management experience & problem-solving skills
- Experienced in regulated quality management systems like for the med device / pharma industries
- Persuasive, effective communication skills are essential with an ability to work effectively across functions, across technical areas, and outside of the company.
- Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills, and sound judgment.
- Experienced in Quality Assurance for manufactured products and processes per standard operating processes (SOP'S) and GMP (Good Manufacturing Practices).
- BS degree and/or 5 to 7 years equivalent experience
Quality Assurance Specialist III - GCP
Onsite – North Chicago, IL
Contract length - Through end of year to start
Hourly Pay Rate: $37-40/hr (individual medical benefits available at a cost)
The Quality Assurance Specialist will be primarily responsible for supporting the Research and Development quality agreement process with a focus on identifying and implementing process improvements. The QA Specialist has a thorough understanding of international GCP regulatory standards and will be supporting & developing the clinical quality agreements process.
Responsibilities:
- Provide an active role within R&D as an expert in GCP requirements. The strategic focus is for early detection and prevention, followed by correction of issues.
- Collaborate with GCP functional areas and assist in the resolution of external partner quality issues.
- Lead or participate in technically complex and strategic cross functional GCP projects.
- Lead or participate in GCP focused strategic initiatives to improve compliance with regulatory requirements and standards.
- Lead or participate in process improvements, including review / update current supporting processes and procedures
- Achieve a difficult balance of involvement, independence, and objectivity.
- May support Clinical Quality Agreement creation and periodic review.
- Consistently demonstrate Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality.
Qualifications:
- Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (5-7 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries.
- Must have good understanding of clinical practices & clinical quality agreements.
- Thorough understanding of international GCP regulatory standards.
- Must have a technical background and extensive knowledge of worldwide requirements for quality systems.
- Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills and sound judgment.
- Persuasive, effective communication skills are essential with an ability to work effectively across GCP functions, across technical areas and outside of the company.
- Accreditation by a professional body is desirable, e.g., American Society for Quality (ASQ) Certified Quality Manager (CQM), Registered Quality Assurance Professional (RQAP), and/or Certified Quality Auditor (CQA).
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Rachael Jalbuena
Recruitment Consultant
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