QA Specialist

Job Description

Duties and 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.
• Assessment of Quality QMS Records (e.g. Deviations and third party or internal complaints), make recommendations for corrective and preventative actions and to 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.
• May participate in Audit/assessments as well as multiple projects of high priority including regulatory inspections and high-risk non-compliance issues.
• Participate in or lead improvement initiatives.

Basic Qualifications:

• Bachelor’s degree or equivalent work experience such as 5+ years in 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 of 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 and inspections/audits and root causing).
• Proficient working knowledge of Microsoft Windows suite of applications (Word, Excel, Power Point).

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.