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6 days old

Quality Analyst

Kelly Services
Thousand Oaks, CA 91358
**Quality Analyst**


**6 month contract**


**Up to 31 an hour**


**Thousand Oaks, CA**


**Summary**

Responsible for performing the day-to-day quality operations for QA Form Finish Manufacturing within the Quality organization. Identify and assess quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.



**Essential Duties & Responsibilities**

Responsible for reviewing pertinent documents, records and reports such a Manufacturing Formulation Records (MFRs), Manufacturing batch Records (MBRs), etc. against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.

Identify areas of non-conformance and inform management via the drafting of Non-Conformance Reports (NCRs) as needed to be disposed (unilaterally accepted or rejected) by others. NCRs at this level are minor and involve no patient risk

Performs initial investigative actions on NCRs, applying well-established techniques and procedures

Administer and maintain relevant databases, preparing and issuing reports as defined by the area.

Assist in external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc.

Revise or review standard procedures. Revise SOPs in support of Division Procedure Compliance or continuous improvement efforts as needed.

Maintain and update departmental business indicators. Prepare metrics for the Management Review of Quality Systems.

Audit/review documents as needed for completeness, cGMPs, company procedures and verification of data. Correct any deficiencies found.

May perform other duties as assigned.



**Qualifications**

Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, and Application of Good Manufacturing Practices.


Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

Must have passion to innovate and drive for solutions.

Must display personal accountability for results and integrity.

Must display eagerness to learn and continuously improve.

Must have uncompromising dedication to quality.

Must have relentless focus on rapid and disciplined action.

Must have respect for individuals and the diverse contributions of all.

Passion for Improving Lives. Must be able to put our patients at the center of everything we do.

Quest for Innovation. Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations.

Inspired Teams environment. Must be able to thrive in diverse high performing teams.

Engaged with the World Around Us. Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.

Education and/or Experience

Associate degree in a scientific discipline and one to three years of relevant experience within most recent 5 years or an equivalent combination of education and experience. Bachelors degree in the life sciences, business or other technical field preferred.

Working Environment



**List the specific working environment that the employee will work in to perform his/her essential duties and responsibilities:**

Normal office environment.

This position requires shift, weekend and holiday work.

May be required to travel for business reasons, e.g. training and meetings.

Must be able to work in controlled or clean room 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 these work environments.

May work in a cold, wet environment.

May be exposed to sunlight and heat.

May be exposed to dust, gases, and fumes.

Possible exposure to cool/hot storage conditions.

May be around moving equipment and machinery.

May work around Metnotrex, which is a known cell growth inhibitor.

May be working in a loud area that requires hearing protection and other protective equipment to be worn.

May work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.

Inside working conditions.

May require immunization before performing work within the manufacturing area.

May be required to work or be assigned to a different shift as needed.

Must be able to work more than 8 hours a day or 40 hours a workweek as required.

Overtime may be required at times.

Will have interaction with other people.

Pace may be fast and job completion demands may be high.

Physical Demand


The overall physical exertion of this position is sedentary.

May be required to walk occasionally when retrieving batch records from the records vault, attending meetings, and visiting the manufacturing areas for observation.


**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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: 2021-09-13 Expires: 2021-10-14

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Quality Analyst

Kelly Services
Thousand Oaks, CA 91358

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