Project Specialist I

As the largest staffing and recruitment agency in the world, we connect job seekers like you with top employers in the life sciences and biopharma industries to achieve their business goals. This role offers the opportunity to serve as an asset to your company while making a difference in others' lives.

Responsibilities

• Serve as a Batch Release Officer for the review and recommended release of documentation for a range of dosage form batches and finished clinical trial packs of Investigational Medicinal Products in accordance with GMP requirements.
• Assess Quality QMS Records (e.g., Deviations and third-party or internal complaints), make recommendations for corrective and preventative actions, and follow up on their implementation.
• Review and approve GMP documentation, including Standard Operating Procedures, Change Controls, and other controlled documents from business partner areas such as Clinical Supply Chain packaging operations and logistics.
• Provide advice and support to business partner areas on quality matters and process improvement.
• Develop and incorporate effective processes and procedures in Quality R&D Supply QA/QP US and contribute to business processes outside of quality.
• Participate in audits/assessments and multiple high-priority projects, including regulatory inspections and high-risk non-compliance issues.
• Lead or participate in improvement initiatives.

Requirements

• Bachelor's degree or equivalent work experience (5+ years in a similar position).
• Experience in QA review of GMP Manufacturing and/or Packaging Documentation and/or laboratory records of pharmaceutical dosage forms, including sterile products.
• Experience reviewing and approving GMP documentation within a Quality Assurance/Quality Control role.
• Knowledge of GMP principles and experience making decisions based on this knowledge.
• Experience leading or participating in QMS activities (e.g., Quality Deviations, third-party/internal complaints, Change Controls, inspections/audits, and root cause analysis).
• Proficient in Microsoft Windows suite of applications (Word, Excel, PowerPoint).

Preferred Qualifications

• Experience working in high-pressure environments with conflicting priorities.
• Knowledge of the R&D process, particularly clinical trials manufacturing and packaging.
• Strong attention to detail and communication skills, with the ability to build relationships and trust while making decisions based on GMP principles.
• Problem-solving and collaboration skills.
• Familiarity with Good Manufacturing Practices (GMP), Quality Assurance (QA), and Quality Management Systems (QMS).

Pay

$45 - 50 per hour

Schedule

9 AM to 5 PM (Contract)

Benefits

• Medical, prescription, dental, and vision insurance.
• AD&D and life insurance.
• Short-term disability coverage.
• 401K plan (eligibility-based).

Location: Morrisville, North Carolina