What are the responsibilities and job description for the GMP Quality Consultant position at Redbock - an NES Fircroft company?
GMP QUALITY CONSULTANT (6-9 months, Possibility of Extension)
SUMMARY:
Consultant needed for remote assignment providing senior-level GMP Quality Operations oversight and SME guidance in support of therapeutic production
DUTIES & RESPONSIBILITIES:
* Review and evaluate compliance of GMP-related documents such as master batch records, executed batch records, deviations, non-conformance, change controls, etc.
* Quality evaluation for outsourced GMP operations and services
* Audit support
* Provide SME feedback, guidance and mentorship to team members
* Related communications and reporting
* Other duties, as required
QUALIFICATIONS & REQUIREMENTS:
* 10 years of relevant focused experience in GMP and FDA-compliant biologics production quality, including significant experience working for both biologics sponsor companies and CDMOs manufacturing biologics
* Proven experience in mentorship, leadership and decision-making for biologics production quality in support of Phase II and Phase III clinical trials
* Hands-on expertise in batch record review, audits and handling quality events
* Excellent written, verbal and interpersonal communication skills
* Willingness and ability to work during Pacific Time business hours
* Relevant degree
LOCATION:
Work can be performed remotely, from home