Contract position: Our client in Monrovia CA is looking for a Contract QAIV to start right away! Must have 9 years of experience and at least 3 years of supervisory- lead experience.Responsibilities for the Senior Quality Engineer
Requirements for the Senior Quality Engineer
- Performs quality assurance activities for equipment, building, processes and products to ensure compliance with Good Manufacturing Practices (GMP).
- Responsible for final review and approval of all project documents, such as SOP's for example
- Coordinate and conduct cGMP audits, follow up and write reports for submission to QA Manager/ Director. Review and implement internal training program. Represent OQS in management meetings. Interface with all collaborators to resolve production, personnel and facility issues.
- Initiate OOS/CAPA investigations, propose resolutions and process related forms.Writes reviews and processes the approval of Standard Operating Procedures. Provide supervision to junior staff on activities as directed. Coordinate or lead several OQS personnel to implement OQS policy.
- MS or BS Degree required with 10+ years of experience in BioMedical, or Life Sciences
- 9+ years of relevant experience. 3+ years of supervisory/lead role experience. Required experience may vary according to QA team focus (i.e. supporting biologics manufacturing, small molecule synthesis, GMP facility operations
- Current Certification from ASQ or RAPS ; Certification from ASQ, RAPS or other professional organization /recognized institutions related to quality (i.e. quality auditor, quality manager, facility operations). Biotech sponsored seminars, workshops on regulations, policies, and procedures impacting cGMP/GLP activities related to biologics manufacturing.
- Contractor Benefits Available!
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.