Quality Assurance Specialist
Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Quality Assurance Specialist to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference!
- BA in Chemistry, Pharmacy, or related science field
- Minimum five (5) years’ experience with BS/BA pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
- Diploma and seven (7) years' experience in pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
Essential Duties and Responsibilities:
- Ability to respond and act appropriately with all levels under time pressure and regulatory scrutiny.
- Escalates and collaborates with quality management to resolve trends impacting product quality.
- Demonstrated knowledge of FDA, cGMP, EU regulations, and USP.
- Demonstrated effectively applying cGMP and quality system regulations within the pharmaceutical industry.
- Demonstrated knowledge of Quality Assurance, Production, Laboratories or Regulatory functions within a pharmaceutical environment.
- Excellent communication skills with the ability to influence/persuade individuals.
- Ability to utilize active listening skills to understand the concerns or reasoning to be responsive, gain trust, and build strategic relationships.
- Project management expertise to arrive at quality effective and efficient processes that contribute to product quality.