QA Associate (Part-Time)
Responsibilities
- Maintain and update the current quality program.
- Create, implement, and revise controlled documents, including Standard Operating Procedures (SOPs), to ensure compliance with current regulatory requirements such as ICH, GCP, CFR, etc.
- Manage deviations and Corrective and Preventive Actions (CAPAs).
- Develop and conduct quality-related training sessions, both internally and externally, as needed.
- Maintain and update company training files as necessary.
- Conduct internal audits of quality systems.
- Conduct service provider and vendor audits.
- Maintain quality system-associated documents.
- Assist with customer audits and regulatory inspections.
Essential Skills
- Experience with Vendor Audits and Standard Operating Procedures (SOPs).
- Strong background in Quality Assurance.
- Familiarity with GCP and ISO compliance.
Additional Skills & Qualifications
- QA experience within a Contract Research Organization (CRO) or Pharmaceutical Company is preferred.
About the Role
We are seeking a dedicated Quality Assurance (QA) Associate to join our team on a part-time basis. The role involves creating and developing a comprehensive quality assurance program to monitor all operational, pharmacy, and sponsor-facing activities. This position ensures compliance with all applicable regulatory, Good Clinical Practice (GCP), and privacy requirements, regulations, and guidelines. The QA Associate will conduct periodic quality checks and auditing activities as required by regulations.
Job Type & Location
This is a Contract position based out of Raleigh, NC.
Pay and Benefits
The pay range for this position is $40.00 - $45.00/hr.
Requirements
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Work Environment
This position is fully home-based, offering flexibility with 5-15 hours of work per week. Our team is part of a niche CRO specializing in Quality Assurance for clinical trials. We are at the forefront of revolutionizing clinical trials by utilizing community pharmacies equipped with dedicated clinical spaces and private consultation rooms as trial sites. Our cutting-edge technology facilitates community-based clinical trials, ensuring equitable access to groundbreaking treatments across diverse communities.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
San Francisco Fair Chance Ordinance
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.