The Quality Assurance Supervisor will work directly with validation project coordinato, technical area representatives, oveeas global quality team and laboratory management. Primary respoibilities are reviewing laboratory records and raw data, supporting the maintenance and integration activities related to the laboratory’s Quality Systems, hosting internal (self-ipection), customer and regulatory audits, and identifying opportunities for and implementation of continuous improvement.

Key duties/respoibilities:

? Review laboratory records and testing data to assess compliance with protocol requirements, laboratory procedures and applicable industry practices

? Perform all function of a document controller, change control, training administrator and nonconformance/CAPA coordinator including, but not limited to the following:

omaintaining/creating documents in the quality database including processing requests for new documents, managing change requests, coordinating document validity reviews, issue controlled documentation for laboratory worksheets

omaintaining training database including learner curricula, learning pla and manual entry of training information

omaintaining nonconformance/CAPA quality database including conducting/documenting investigatio, determining root cause and assigning corrective/preventative actio

?Provide supervisor support on selected, large-scope projects as needed

?Develop expertise in drug and medical device cGMP regulatio and ISO 9001 standards to provide guidance, training and compliance assessments as needed

?Laboratory representative on quality system virtual user group teams

Required Experience, Skills and Training

?Minimum 3 yea in a quality assurance or quality control role, Pharmaceutical companies background preferred

?Minimum 3 yea in a cGMP or ISO environment

?Experienced operator or data quality reviewer for GC, LC itrumentation preferred

?Proficient with Microsoft Word and Excel

?Excellent written and verbal communication skills

?Certified Quality Auditor or equivalent preferred

?Experience with cGMP calibration and validation protocol and report review/approval

?Familiar with CFDA regulatio

Preferred Experience, Skills and Training

?Worked in a laboratory

?Working knowledge of laboratory information databases such as Trackwise

?Can communicate effective verbally in English

?Thorough undetanding and practical application experience of Quality Risk Management

?Lean & Six Sigma or Operational Excellence training/certification

?Thorough undetanding and practical application of 21CFR Parts 11, 210, 211 and 820

Education

?Bachelor or Master degree in a life science, Analytical chemistry background preferred