inSync Staffing
Quality Compliance Associate
inSync Staffing, Novato, California, United States, 94949
Quality Compliance AssociatePay Rate $33.00/hour - $36.00/hourDuration 6 month contractLocation Novato, CA
Support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activitiesSupport 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 BioMarin departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessaryInterpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directivesOther duties as assigned
Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processesExcellent written, verbal, analytical, and interpersonal skills
BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment
Benefits:•Health insurance•Health savings account•Dental insurance•Vision insurance•Flexible spending accounts•Life insurance•Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.#IND10
Support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activitiesSupport 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 BioMarin departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessaryInterpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directivesOther duties as assigned
Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processesExcellent written, verbal, analytical, and interpersonal skills
BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment
Benefits:•Health insurance•Health savings account•Dental insurance•Vision insurance•Flexible spending accounts•Life insurance•Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.#IND10