Quality Specialist

Responsibilities:

• The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
• The role will support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality related documentation.
• The successful candidate will support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas which also includes getting certified for Grade A/B gowning.
• The role follows cGMP and routinely makes decisions using cGMP/process knowledge. 

​​Qualifications:

• Previous Experience in the pharmaceutical industry.
• Previous experience supporting aseptic operations or sterile product, experience in Quality Assurance/Engineering role or Technical role.
• Previous experience in food or pharmaceutical environment in regulatory/inspection role.

Education Requirement: Bachelor's Degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience.