Quality Assurance Team Lead - Vista, CA | Biospace
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Quality Assurance Team Lead

Bachem

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Location:
Vista, CA
Posted Date:
11/17/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manufacturing, QA,

Job Description

•   GMP compliance improvements.
•   Lead QA team in supporting manufacturing activities.
•   Oversee work of direct reports; distribute workload, and cross-train staff.
•   Oversee deviations, CAPA and product complaints.
•   Provide GMP and related training to company employees.
•   Provide cGMP compliance guidance to other departments.
•   Writing new and revising current standard operating procedures (SOPs), specifications, etc.
•   Conduct internal audits and write audit reports.
•   Reviewing all GMP documentation, including BPRs and monitoring data.
•   Reviewing trending data.
•   Provide support to customer and regulatory audits.
•      Recommends and implement new policies and procedures to improve existing         processes and products
•     Writing and reviewing validation protocols, reports and master plans.
•     Problem resolutions with GMP systems
•     Assist in the supervision of QA Specialists in supporting of manufactur

Requirements

•   BS degree in Science discipline - Chemistry, Chemical Engineering, Biology or equivalent
•   Minimum of 5 years’ experience in GMP compliance
•   Experience in GMP manufacturing environment, Quality Assurance and Quality Control
•   Experience with GMP document control
•   Ability to lead QA team in supporting manufacturing activities.
•   Extensive experience in internal auditing as well as working with regulatory agencies
•   Ability to effectively organize, multitasks, and works in a fast-paced, deadline driven work   environment.
•   Ability to communicate in a proactive and solutions-focused manner, including keeping      management aware of potential issues.
•   Strong computer skills.
•   Excellent written and oral communications skills
•   Ability to work independently and manage one’s time
•   Communicate effectively and ability to function well in a team environment