1+ months

Quality Assurance Specialist

Kelly Services
Davis, CA 95618
**Job title: Quality Assurance Manager**

**Job type:** Full time

**Job Description** : Our client was founded in 1960 to provide essential products for the growing immunology market. In the years since our clients founding, the team has grown into a 40-acre campus comprised of laboratories, manufacturing and animal care facilities. Our manufacturing group is a partner to some of the worlds leading life sciences companies while our contract research group provides custom antibody services and IVD development for a diverse clientele including pharmaceutical and biotech companies as well as academic researchers. They also proudly offer an extensive catalog of highly-validated neuroscience antibodies which serve as a valuable resource to neuroscientists worldwide.

As a small company each of our employees has a sense of being directly connected with our success. If you are someone who enjoys working on a variety of projects and having the opportunity to actively contribute to growing a company, AI may well be the place for you!

**Job description:** The QA Manager will be responsible for maintaining an effective Quality Management System (QMS) in accordance with FDA 21CFR820 and ISO 13485 standards. Responsibilities include, but are not limited to:

+ Lead internal audits and host external audits (BSI, FDA)

+ Review and approve batch records and production records for conformance to established specifications.

+ Maintain document control management practices (master document list, new document implementation, document change control)

+ Maintain equipment management practices (validations, internal/external calibration)

+ Manage non-conformances, CAPAs, complaints

+ Manage design control and development activities (review and approve validation and verification plans)

+ Ensure all regulatory licenses and certifications are current

+ Advise (and when appropriate) coach and train personnel to ensure all activities are in compliance with our Quality Management System.

**Requirements** :

+ B.A./B.S. degree.

+ At least 2 years quality assurance experience in a cGMP/ISO manufacturing environment (preferably in life-science field).

+ Knowledgeable on current FDA and ISO standards and regulations

+ Lead auditor certified (preferred).

**Skills** :

+ Must be highly organized and detail-oriented.

+ Self-assured professional who is capable of providing institutional leadership in the area of quality assurance.

+ Must be approachable and willing to provide assistance/consultation in: resolving non-conformances, planning validations and verifications, product/service development.

+ Have continuous improvement mindset and desire to improve current processes

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

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**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: 2020-08-19 Expires: 2020-09-19

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Quality Assurance Specialist

Kelly Services
Davis, CA 95618

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