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20 days old

Quality & Technical Engineer

Kelly Services
Santa Ana, CA 92702
**Title:** Quality & Technical Engineer


**Location:** Irvine, CA


**Job Description:**

This role is a critical position to the Quality Systems and Regulatory team. Provides statistical information for quality improvement by identifying and implementing efficiencies, such as new or improvements for assay method identification, development and transfers to GMP, Stability Program, Risk Assessments of the various product and processes changes with focus on leading and driving continuous improvement with the objective to build capability within the organization to eliminate risk and improve efficiencies.


**Responsibilities:**

_Includes the following. Other duties may be assigned. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.?_


Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.

Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence.

Establishes statistical reliability by using mean time before failure, 3-parameter distribution, reliability modeling, and reliability demonstration tests.

Develops experiments by applying full and fractional factorial techniques as well as experience in cell Culture Company.

Develops sampling plans by applying attribute, variable, and sequential sampling methods.

Maintains statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions and individual-medial/range for multi-stream processes.

Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.

Prepares reports by collecting, analyzing, and summarizing data; making recommendations.

Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies; maintaining American society of quality control certified quality engineer qualification.

Provides support with the sister companies and affiliates during their process and product transfer, such as IST.

Contributes to team effort by accomplishing related results as needed.

Able to establish and maintain highly productive interdepartmental cooperative relations.

Works in alignment with the sales force, product manager, quality assurance, quality control, R&D and materials.

Requires substantial independent judgment, creativity and self-motivation.

Provides for testing of all company products.


**Education Requirements:**

BS/BA in Microbiology, Biology or Chemistry; advanced study in Microbiology is highly desirable.


**Experience Requirements:**

5 or more years of biological or microbiological laboratory experience.


**Qualifications:**

Good skills in tissue culture, biochemical, and microbiological testing methodologies.

Ability to analyze information and report research findings

Strong Technical Understanding

Promoting Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation, CAD, Quality Engineering, Operations Research

Detailed understanding of 21 CFR Part 211, 21 CFR Part 820, ISO 13485, Canadian MDR, MDD 93/42 with emphasis on laboratory testing, material specifications, and related areas.

Ability to speak, write, and read English well.

Good oral and written communication skills.


**Required Training:**

Refer to Quality Systems Manual, QSM-001.


**Equipment Use:**

Spectrophotometer, FTIR, Cell Counter, Chemistry Analyzer, coolers, refrigerators, pH meters, Osmometers, and all related laboratory equipment.


**Physical Demands:**

_Described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to read, compile, compute and record numerical and statistical data._

Duties require the use of hand dexterity to manipulate fluids and powders to perform applicable tests in clean room environments, laminar flow hoods, and laboratory benches.

The employee is frequently required to stand. The employee is occasionally required to walk, sit, use hands to handle, feel or reach with hands and arms; climb or balance; and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, and depth perception.


**Work Environment:**

_The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job._

The noise level in the work environment is that of a busy laboratory office with telephones, computers and printers operating and with frequent people interruptions.

Required to perform duties in a laboratory environment with required dress and hygiene.


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Jessica at jessica.rubano@kellyscientific.com_**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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: 2021-11-12 Expires: 2021-12-13

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Quality & Technical Engineer

Kelly Services
Santa Ana, CA 92702

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