Life Sciences Manufacturing Quality Assurance Consultant
Must be an expert on what is required to be captured in a batch record based on international regulations. Assess MES related CAPAs and inspection commitments. Change control QA contact role. Provide guidance on global SOP content and approve documents. Work with MBR designer and process engineer to develop and approve batch records. Assess site QA SOPs for need to change. Provide guidance on SOP content. Provide Quality input to MES related standards/guidelines. Approve site batch record objects. Serve as QA approver for legacy site documentation removal and revision of impacted documents.
Minimum of 3 years of experience with life sciences manufacturing solutions
Knowledge of FDA and GMP guidelines
Ability to work in a team-oriented, collaborative environment
Understanding of Life Sciences validation processes
Change Management
Time Management Skills
MS Excel skills
Analytical skills (data driven)
Verbal communication
Driven and self-motivated
written communication
Adaptability
Problem Solving Skills
Detail Oriented and Organized
Multi tasker
According to JobzMall, the average salary range for a Life Sciences Manufacturing Quality Assurance Consultant in 201 S College St, Charlotte, NC 28202, USA is between $53,000 to $87,000. This salary range depends on factors such as the individual's experience in the field, the size of the company, and the industry.
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