Quality Assurance Specialist Job Listing at Kelly Services in Houston, TX (Job ID US3531549_BH9718756)

Description

Quality Assurance Specialist-Houston, TX 

Kelly Science & Clinical is seeking a Quality Assurance Specialist for one of our clients, a biopharma/biotech company, located in Houston, TX.

Essential Duties and Responsibilities:
•    Review and approval of Quality System and cGMP documents including, but not limited to, SOPs, Batch records, protocols and specifications. 
•    Review and approval of change controls, non-conformances, OOS, deviations, complaints and related items; ensure investigations are thoroughly investigated and resolved.
•    QA review of manufacturing and QC related records, resolution of all related issues and QA disposition of product batches.
•    QA review and disposition of raw materials, buffers and other components.
•    QA review of initial qualification, validations and re-validations for facilities, equipment and processes.
•    QA support of GMP training program
•    Internal and external compliance auditing; follow-up of audit CAPAs.
•    Responsible for generation, inspection and release of labels.
•    Responsible for maintaining the company's controlled documents in accordance with GxP requirements.
•    Work closely with cross functional teams to ensure all work is completed to high quality in a timely and scientifically rigorous manner.

Job Requirements:
•    Bachelor's degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field
•    At least 3 years of relevant experience in the biotech/pharmaceutical industry
•    Working knowledge of cGMP requirements for biologics manufacturing. 
•    Working knowledge of requirements for aseptic manufacturing. 
•    Basic knowledge of cell biology, cell culture.
•    Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines. 
•    Excellent communication skills, both verbal and written, required. 
•    Problem solving skills and ability to make quality decisions based on technical facts and sound risk assessments is required.

Job Details:

•    Contract-to hire
•    Monday – Friday, 1st/Day: 8:00 AM – 5:00 PM
•    Pay rate dependent upon level of education and experience 
 

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

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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