Onsite: Novato
Duties:
Support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activities.
Support or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
Adhere and follow cGMPs guidelines and procedures.
Escalate non-compliance concerns to management.
Interface with other departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessary.
Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives.
Other duties as assigned.
Skills:
Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processes.
Excellent written, verbal, analytical, and interpersonal skills.
Education:
BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment.
The hiring range for this position is $30 to $34 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.
Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.
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