Quality Assurance Specialist I

Kelly Science & Clinical is excited to present the Quality Assurance Specialist I, Supplier Quality position, focused on raw material inspection in a Global Biopharmaceutical company.

This role is crucial in ensuring that raw materials meet regulatory requirements and quality standards.

• Location : Seal Beach, CA
• Shift : M-F Day Shift
• Pay : $30-34 / hour (DOE)
• Type : Temp-to-Hire

Key Responsibilities :

Raw Material Testing :

Plan, organize, oversee, and perform raw material testing in collaboration with contract testing laboratories, vendors, and warehousing.

Communication :

Liaise with Quality Assurance and Materials Management departments to ensure timely delivery of test results and issuance of Certificates of Analysis (CoA).

Procedure Management :

Maintain up-to-date raw material standard operating procedures according to manufacturers' manuals and recommendations.

Material Specifications :

Revise and manage material specifications.

Non-Conformance Investigations :

Participate in non-conformance investigations, providing technical expertise and guidance for material-related issues.

Cross-Functional Support :

Offer technical expertise and testing support to other departments in cross-functional project teams.

Raw Material Activities :

Support activities related to sample and reagent management.

Job Requirements : Education :

Education :

Bachelor's degree in a scientific discipline or equivalent.

Experience :

• Typically, 1 year of related experience in a cGMP / FDA regulated industry.
• Preferred experience in raw material testing and release, as well as ANSI sampling and inspection methodology.

Regulatory Knowledge :

Familiarity with cGMP / QSR and FDA device / drug / biologics regulations.

Skills :

Proficient in MS Office applications.

Working Conditions and Physical Requirements :

Equipment and Materials :

Limited use of laboratory equipment, chemicals, and biological materials.

Physical Abilities :

• Ability to sit or stand for extended periods.
• Intermittent walking to access work areas.
• Finger dexterity for computer use and paperwork.
• Vision sufficient for reading and paperwork activities.
• Hearing sufficient for communication via telephone and in person.
• Ability to lift up to 25 pounds.

Environmental Conditions :

• Work performed in a lab, office, or utility (noisy) environment.
• Limited exposure to temperatures of (2oC - 8oC), (-20oC), (-75oC), and (-196oC).

Safety Precautions :

Ability to work in laboratories and manufacturing areas with exposure to blood, blood products, or other potentially infectious materials while wearing required personal protective equipment.

Application Process :

Please quick apply, and a Kelly recruiter will contact you.

Thank you!

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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources.

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.

As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you.

Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals it's the way we think job searching should be.

Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

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