Quality Assurance Specialist

Qualifications

• A Bachelor’s Degree (B.S.) in Chemistry, Biology, Microbiology or Pharmacy related field is preferred.
• A minimum of 1-3 years’ experience in an FDA-regulated environment within Quality Assurance department and experience with control of documents.
• A good understanding of cGMP regulations as they apply to Drugs and Medical Devices is required.
• Ability to enforce adherence to internal quality policies, procedures and cGMP.
• Ability to interface and work with a diverse group of departments and individuals is required.
• Must be team oriented with excellent interpersonal skills. Must have the ability to express regulatory requirements clearly and understandably.
• Must possess good oral and written skills in the English language.

Essential Duties and Responsibilities

• Participate in the design and development of Lupin’s Quality Systems and provide support of continuous improvement and management of Quality Systems.
• Liaison with SMEs and stakeholders to ensure documents are accurate, complete, and delivered within timelines.
• Collaborate with functional departments to identify additional procedural controls for overall improvement of compliance.
• Support internal and to 3rd party audits at LIR site.
• Partnership with other functional areas (Operations, Product Development, Quality Control, Engineering and Facilities, Manufacturing, and Supply Chain) to ensure site continuous compliance.
• Support employee training program.
• Management of QA retain samples and archival of GMP documents.
• Provide support in the documentation of investigations and Root Cause Analysis.
• Perform other QA duties as assigned.