QA Specialist

About the role

Ensuring quality and compliance of Investigational Medicinal Products used worldwide.

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 the implementation of those recommendations.
• Review and approve GMP documentation, which may include 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 relating to quality matters and process improvement.
• Develop and incorporate effective processes and procedures in Quality R&D Supply QA/QP US and may contribute to business processes and procedures outside of quality.
• Participate in audits/assessments as well as multiple projects of high priority, including regulatory inspections and high-risk non-compliance issues.
• Participate in or lead improvement initiatives.

Requirements

• Bachelor's degree or equivalent work experience such as 5+ years in a similar position.
• Experience of QA review of GMP Manufacturing and/or Packaging Documentation and/or laboratory records of pharmaceutical dosage forms, which may include sterile products and/or review and approval of GMP documentation within a Quality Assurance/Quality Control role.
• Experience or knowledge of GMP principles and being a decision-maker using this knowledge.
• Experience leading or participating in QMS activities (e.g., Quality Deviations, third-party/internal Complaints, Change Controls, inspections/audits, and root causing).
• Proficient working knowledge of Microsoft Windows suite of applications (Word, Excel, PowerPoint).

Preferred Qualifications

• Experience working in high-pressure environments where there are likely to be conflicting priorities.
• Knowledge of the R&D process, particularly with respect to clinical trials manufacturing and packaging.
• Strong attention to detail.
• Good communication skills with the ability to build relationships and trust; and make decisions based on GMP principles, problem-solving, and collaboration.

Pay

$45-55/hr