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24 days old

Quality Assurance Specialist (Pharmaceutical)- Irvine, CA

Kelly Services
Irvine, CA 92604
**Quality Assurance Specialist** Irvine, CA


PERFORMS ONE OR MORE OF THE FOLLOWING QA SPECIALTIES:


+ Performs and/or assists with QA review of production records and Lab reports.

+ Investigates non-conformance and deviation reports.

+ Coordinates the stability studies including reviewing laboratory reports for accuracy and preparing statistical analyses of decay curves.

+ Review test results for and release raw materials.

+ Audits production and quality control programs, reports observed deficiencies, and contributes to establishing solutions to observations.

+ Issues batch records, checks yield and reconciliation calculations, and file records for easy retrieval.

+ Manages validation programs related to manufacturing equipment and processes and calibration of physical testing equipment.

+ Receives, logs, investigates, and reports on complaints and adverse events; coordinates responses with QA Manager.


COMMON DUTIES:


+ Creates and revises standard operating procedures as necessary.

+ Assures compliance with cGMP regulations and all standard operating procedures.


ASSOCIATED DUTIES AND RESPONSIBILITIES:


+ Assist in preparation for internal, customer and agency audits.

+ Assist in ensuring all personnel comply with cGMP regulations and follow all standard operating procedures.

+ Assist with raw material management systems.

+ Use of statistical process control to evaluate tends.

+ Other related duties as required.


REQUIRED SKILLS, ABILITIES, AND QUALIFICATIONS:


+ Bachelors degree in a scientific discipline or 4 years experience in a quality control or quality assurance function associated with manufacturing.

+ Ability to read and interpret technical procedures, SOPs, GMPs and governmental regulations.

+ Strong communication skills, both written and verbal.

+ Ability to effectively present information and respond to questions.


**Apply Today!** Questions? Please call Airika at 562-206-2707 or email at **airc843@kellyscientific.com**

To schedule a time to connect, please click the link to add your availability to my calendar. **https://calendly.com/airc843/30min?month=2020-09**



**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/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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-05-28 Expires: 2021-06-28

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Quality Assurance Specialist (Pharmaceutical)- Irvine, CA

Kelly Services
Irvine, CA 92604

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