Project Specialist I – Quality Assurance

Location: Zebulon, NC
Pay Rate: $45–$50/hour
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Hours: 40 hours/week
Work Setting: Onsite, 5 days per week
Position Type: Contract

Position Overview

We are seeking a Project Specialist I – Quality Assurance to support quality and compliance activities for Investigational Medicinal Products used in clinical trials worldwide. This role will work closely with Quality, Clinical Supply Chain, Manufacturing, Packaging, Logistics, and other business partners to ensure GMP compliance and timely completion of quality activities.

The ideal candidate has experience in pharmaceutical Quality Assurance/Quality Control, GMP documentation, batch release, deviations, change controls, complaints, audits, and CAPA and is comfortable making quality-based decisions in a fast-paced environment.

Key Responsibilities

• Serve as a Batch Release Officer, reviewing documentation and recommending release of dosage-form batches and finished clinical trial products in accordance with GMP requirements.

• Review and assess Quality Management System (QMS) records, including deviations, complaints, investigations, and CAPA activities.

• Review and approve GMP documentation, including SOPs, change controls, manufacturing/packaging records, and other controlled documents.

• Provide Quality Assurance guidance and support to Clinical Supply Chain, Packaging, Logistics, and other business partner teams.

• Identify opportunities for process improvement and support implementation of effective quality processes and procedures.

• Participate in and/or lead quality improvement initiatives and high-priority projects.

• Support audits, assessments, regulatory inspections, and investigations involving significant compliance issues.

• Apply GMP principles to quality decisions and ensure appropriate follow-up on corrective and preventive actions.

• Collaborate with cross-functional teams to resolve quality issues and maintain project timelines.

• Maintain accurate documentation and communicate quality risks, decisions, and recommendations to stakeholders.

• Balance multiple priorities while maintaining a strong focus on compliance, product quality, and patient safety.

Required Qualifications

• Bachelor's degree or equivalent work experience, such as 5+ years in a similar pharmaceutical Quality Assurance/Quality Control position.

• Experience reviewing GMP manufacturing, packaging, or laboratory documentation for pharmaceutical products.

• Experience working within a Quality Assurance or Quality Control environment.

• Strong understanding of GMP principles and the ability to make quality decisions based on regulatory requirements.

• Experience with QMS activities, including:

  • Deviations

  • Complaints

  • Change Controls

  • CAPA

  • Root Cause Investigations

  • Audits and Inspections

• Proficiency with Microsoft Word, Excel, and PowerPoint.

• Strong attention to detail and documentation skills.

Preferred Qualifications

• Pharmaceutical or biotechnology industry experience.

• Experience supporting clinical trial manufacturing and packaging.

• Knowledge of Research & Development (R&D) processes and clinical supply operations.

• Experience working in a high-pressure environment with competing priorities.

• Strong problem-solving and decision-making abilities.

• Excellent written and verbal communication skills.

• Ability to build strong relationships and collaborate effectively with cross-functional teams.

• Experience supporting regulatory inspections or high-risk compliance investigations.

Why Consider This Opportunity?

• $45–$50/hour

• Monday–Friday, first shift

• Consistent 40-hour workweek

• Opportunity to work within a highly regulated pharmaceutical environment

• Exposure to GMP, clinical trial supply, Quality Systems, and regulatory compliance

• Opportunity to contribute to projects directly supporting investigational medicines and patient safety

Ideal Backgrounds: Quality Assurance Specialist, QA Specialist, Quality Control Specialist, GMP Specialist, Pharmaceutical QA Specialist, Clinical Supply QA Specialist, or QA Project Specialist.

Pay Details: $45.00 to $50.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: 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.