QA Specialist 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 ofInvestigational 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 followup on the implementation of those recommendations.

Procedures, Change Controls and other controlled documents from business partner areassuch as Clinical Supply Chain packaging operations and logisticsprocess improvement.

QA/QP US and may contribute to business processes and procedures outside of qualityincluding regulatory inspections and high-risk non-compliance issues. Review and Approve GMP documentation, which may include Standard Operating Provide advice and support to business partner areas relating to quality matters and Develop and incorporate effective processes and procedures in Quality R&D Supply May participate in Audit/assessments as well as multiple projects of high priority 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 QualityAssurance/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.

Pay:

$42.00 per hour

Work Location:

In person