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7 days old

Quality Assurance Technician

Kelly Services
Los Angeles, CA 90006
Quality Technician


Up to 41 an hour


Los Angeles, CA


1 year contract


Job Details:

Successfully perform all primary activities which include providing daily quality assurance to operations, review and release of batch records and associated documents within the manufacturing facility, provide support on change control processes, and participate and support internal and external audits.

Assure compliance with GMP, GDP, GLP, and company procedures. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, and Quality practices.

Review and release batch records and associated documents against procedures for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines, etc.

Provide assessments to support day to day in accordance with internal procedures and ensure compliance with the FDA and ISO requirements.

Good understanding and knowledge of current regulatory requirements i.e., FDA, ISO, and Shire Quality Systems, and serve as a plant resource for compliance to these requirements.


Essential:

Partner with shift manufacturing to ensure sound quality decisions are made.

Provide oversight to ensure a GMP area is maintained for the Building 8 area on shift.

Obtain resolution on areas identified as nonconformance. Interpret and evaluate results in terms of acceptability to standards, procedures and regulatory requirements.

Performs initial investigations CAPAs, and User Interventions.

Identify areas for improvements to mitigate recurring non-conformances and drive continuous improvement.

Review and release batch records and associated documents against Standard Operating Procedure (SOPs) for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines, etc.


Support and execute project(s) as assigned by management.

Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.

Assist in external and internal audits by collecting and reviewing documents as assigned by management.

Support activities for another section or department as assigned by management.


Have the ability to operate in a dynamic, cross-functional environment.

Be able to be flexible.

Result Driven- manufacturing process simplification and also yield improvement ideas, generate breakthrough solutions.

Be able to have great attention to detail is necessary.

Be able to handle multiple tasks and projects concurrently

Have strong organizational skills and the ability to plan, follow-up, and implement tasks.

Have good critical thinking and problem solving skills (DMAIC, Six Sigma, and Lean).

GEMBA - good investigational experience who goes to the floor see the actual process where event occurred and who also implement robust Corrective Actions for the correct Root Causes.

Yellow Belt/Green Belt training/certification preferred.

Have good verbal and written communication skills.

Have general knowledge of biotech manufacturing theories and processes.

Have knowledge of FDA and EMA Regulations, Application of Good Documentation Practices (GDP), and application of current Good Manufacturing Practices (cGMP).

Be able to perform and analyze trending through the use of DeltaV system.

Be able to generate spreadsheets and power point presentations on the computer.

Be able to support departmental / plant goals.

Be able to review and approve investigations

Be able to work independently and with intermittent supervision.


Education

Bachelors' degree in science, engineering or other related technical field strongly preferred. Some related work experience preferred


Working Environment

Must be able to lift, push, pull and carry up to 10 lbs.

In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

Will work in a cold, wet environment.

Must be able to work multiple shifts, including weekends.

Must be able to work overtime as required.

May be required to work in a confined area.

Some Clean Room and cool/hot storage conditions.


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-02-19 Expires: 2021-03-22

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Quality Assurance Technician

Kelly Services
Los Angeles, CA 90006

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