Seeking a Quality Specialist for our client – a leading global pharmaceutical company specializing in the development and manufacturing of a variety of well-known pharmaceutical drugs, vaccines and animal-health products.
*Position may require shift work 2-3 times per year, for a period of 5 days. Must be flexible to accommodate this need.*
Responsibilities:
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.
Supports the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures and other quality related documentation.
Support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas which also includes getting certified for Grade A/B gowning.
May perform quarantine functions and accountability reviews.
Follows cGMP and routinely makes decisions using cGMP/process knowledge.
Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols.
Qualifications:
Bachelor’s Degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience.
Previous Experience in the pharmaceutical industry.
Previous experience supporting aseptic operations or sterile product, experience in Quality Assurance/Engineering role or Technical role
732-661-0400
info@astrixinc.com