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Quality Assurance Specialist

Eastridge Workforce Solutions Tustin, CA

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Well established Biopharmaceutical company in Central OC is looking for a Quality Assurance Tech

This is a great way to get your foot in the door of an amazing company that offers room for growth, great benefits and nice work environment.

This is a direct hire position Morning shift. Sun-Wed or We-Sat. Must have the ability to work overtime .

Summary/Objective:
The Quality Assurance Specialist provides compliance oversight of Manufacturing production activities. Supports the review of batch records and quality investigations. Performs assigned tasks and works to achieve company goals and department objectives.

Essential Functions:

● Review of batch production records and quality investigations

● Review of Manufacturing forms and paperwork in association with Batch Production Records

● Advise production on proper documentation requirements as needed

● Initiate deviations, assist in area investigations, and review of discrepancy reports

● Maintain a state of inspection readiness

● Maintain company quality and safety standards

● Collaborate with Management to establish and meet targets and timelines

● Independently manage competing priorities with limited instruction

● Serve as a Quality representative on cross-functional and multi-site teams

● Identify and recommend solutions to potential procedure, process and system gaps

● Represent Quality Assurance on multi-disciplinary project teams

● Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs

● Follow company policies and procedures

● Perform tasks as requested by Management to support Quality oversight activities

● Perform other duties as assigned by Management

 

Required Education and Experience:

● B.S. degree in the Life Sciences field

● Minimum of 2 - 4 years of experience in the biopharmaceutical industry

● Must be able to gown for a class 10,000 cleanroom environment

● Proficient knowledge of cGMP

● Ability to interpret Quality standards for implementation

 

Skills:

● Ability to make sound compliance-related decisions with minimal supervision

● Must have strong attention to detail

● Proficient knowledge of cGMP

● Strong communication (written and verbal) and organizational skills

● Strong problem solving and teamwork skills

 

"Eastridge Workforce Solutions is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees"

 

Eastridge Workforce Solutions

Why Work Here?
Medical device company offering great benefits, the opportunity for advancement, and getting paid to learn

Address

Tustin, CA
92780 USA
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