QA/Doc Control - Raw Materials (GMP/ISO) Job Listing at Kelly Services in Oceanside, CA (Job ID 9330520)

Description

PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please (1) apply and (2) email your resume directly to: Regan.Brown@KellyScientific.com.

Kelly® Science & Clinical is seeking a Quality Assurance Specialist I for a direct hire position at a leading client in Oceanside, CA. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate:
$52K-62,400/Year (commensurate with experience)

Overview:
The Quality Assurance Specialist I is a crucial role in conducting all aspects of Quality Assurance within KLS's assigned business project portfolio. This role is responsible for facilitating and implementing quality assurance standards based on cGMP, ICH, and ISO requirements across all KLS products. The incumbent in this position is detail oriented, adept at data entry, has good communication skills, possesses the ability to follow directions exactly as given, and be capable of working with limited supervision. Ability to write and review SOPs and reports is highly desirable.

Schedule:
Monday-Friday, 1st: Flexible Start, 7:00-8:00 AM

Responsibilities:

• Order fulfillment support to include (but not limited to): Line clearance support for packing activities, product packing documentation verification and review, and final label review.
• Incoming inspection of raw materials and packaging components. Issue applicable controlled QC test records and submit to QC.
• Issue controlled batch record documentation to Production.
• Review completed raw material documentation, packaging component documentation, finished product batch record documentation and associated QC test records for compliance against applicable regulations, policies, and current standard procedures.
• Release and issue material and finished products labels for Production use and/or order fulfillment.
• Assist with the controlled document change and revision process.
• Photocopy, scan and file e-documents and hard copy documents.
• Collate reports and documents for/from Production, QC and QA.
• Preparing documents for long term archival.
• Creating and updating training folders.
• Issue, maintain and periodically review equipment logbooks and calibration/qualification records.
• Under supervision, assist in the execution of quality audits.
• Under supervision, assist with the initiation and documentation of quality events (e.g.: deviations, CAPA, change control, complaints).
• Other duties as assigned or identified.
   

Qualifications:

• Bachelor's degree in science or equivalent work experience.
• Experience (1-2 years) working in a GXP or ISO regulated environment.
• Must have excellent skills in organization, problem solving, and time-management.
• Able to attend to detail and act decisively.
• Ability to work under pressure, manage several tasks at once and meet tight deadlines.
• Must have excellent interpersonal, written, oral presentation and verbal communication skills.
• Proficient in Microsoft Word, PowerPoint, Access and Excel.

Physical Job Requirements:

• Office/Lab environment.
• Lifting up to 20 pounds may be required.
• While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear.
• They are required to stand, walk or sit, as well as reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.

What Happens Next:
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

#P1

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® Technology?

Looking to put your tech expertise to work on today's most intriguing, innovative, and high-visibility projects? By partnering with Kelly Technology, you'll gain direct connections to top companies around the globe. Our team creates expert talent solutions to solve the world's most critical challenges. In a world where change is the only constant, our extensive network of industry relationships and IT market expertise help you take your skills exactly where you want to go. We're here to help you gain experience, make an impact, and grow your tech career.

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.

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