Clinical and QA Associate
Clinical and QA Associate (Biotech/Pharmaceutical Industry)
Location: San Diego, CA (Open for U.S. citizens, preferably locals)
Positions: 2
Pay: $23 - $28/hour
Duration: 3 months (possible temp-to-hire)
Shift: Monday - Friday, 8:00 AM - 4:30 PM
Work Type: Onsite
Who We Are
ProQuality Network is a trusted partner in recruiting top talent for the pharmaceutical, biotech, and medical device industries. We connect consultants with meaningful contract opportunities that align with their skills and career goals. When you join our network, you represent ProQuality Network at client sites, adhering to our core values of integrity, excellence, and collaboration.
This role is a contract opportunity with ProQuality Network. The selected consultant will represent our network at our client’s site and play a key role in ensuring compliance with regulatory standards and quality systems.
Position Overview
As a Clinical and QA Associate, you will perform varied tasks under general supervision. You will be responsible for supporting quality assurance activities in compliance with FDA guidelines, GXPs regulations, and internal SOPs. This role offers an excellent opportunity to contribute to the manufacturing and quality operations of a leading organization in the industry.
Key Responsibilities
- Inspect incoming materials for GMP production.
- Assist with packaging floor activities, including equipment/room approval, facility compliance, auditing, label inspection, and line clearance.
- Review production batch records, logbooks, and other associated documents.
- Perform Quality verification of just-in-time labeling activities.
- Manage document issuance, scanning, filing, and archival activities.
- Revise SOPs, work instructions, and forms as needed.
- Support efficiency improvement projects under guidance.
- Ensure products are manufactured, packaged, and tested according to applicable FDA and MHRA guidelines and internal SOPs.
- Participate in quality programs, procedures, and controls to maintain established standards.
- Gather data, manage investigations, and ensure timely resolution of deviations.
- Follow Good Documentation Practices (GDPs) and cGMPs to ensure compliance.
- Respond to and interact professionally with internal and external clients.
Qualifications
Education: Associate’s degree or equivalent knowledge and experience.
Experience: Six Sigma or ASQ certification preferred.
Skills and Abilities:
- Strong problem-solving skills and ability to follow written and verbal instructions.
- Proficiency in identifying, classifying, and controlling the status of incoming materials.
- Excellent communication skills to interact with internal and external clients.
- Ability to multitask, work under pressure, and meet deadlines.
- Solid understanding of quality systems, mathematical reasoning, and scientific principles.
- Physical ability to perform tasks, including lifting up to 40 pounds and using a respirator as required.
Why Join Us?
This is more than just a job—it’s an opportunity to make an impact in a fast-paced, customer-focused, and collaborative environment. You’ll gain valuable experience in quality assurance and compliance while contributing to meaningful projects in the life sciences industry.
If this role aligns with your skills and career goals, we encourage you to apply inside the job description with an updated resume or share this opportunity with your network.
Take the next step in your career by joining the ProQuality Network. Let’s shape the future of quality together!