Quality Assurance Specialist II - Vista, CA | Biospace
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Quality Assurance Specialist II

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:
QA, Quality Assurance,

Job Description

ESSENTAIL FUNCTIONS AND RESPONSIBILITIES

•   GMP compliance improvements.
•   Perform GMP audits for all internal operations
•   Oversee deviations, CAPA and product complaints.
•   Provide cGMP compliance guidance to other departments.
•   Writing new and revising current standard operating procedures (SOPs),           specifications, etc.
•   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

Requirements

Required:
•   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, validation, qualification and calibration
•   Ability to work in ISO7 and ISO8 control environment and support real time batch record review
•   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.
•   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
•   Basic computer knowledge, including Microsoft Word and Excel (used daily)
•   Detail oriented with the ability to troubleshoot and resolve equipment problems