Quality Assurance Specialist I

Job details

Pay

$27 - $30 an hour

Job type

Full-time

Shift and schedule

Extended hours

Monday to Friday

Work setting

In-person

Office

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Retirement plan
• Vision insurance

Full job description

Kinovate Life Sciences, Inc. established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (www.nitto.com), Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (www.ndtcorp.com) with a mission to provide the highest quality materials to niche life science markets worldwide.

Since its inception, Kinovate has grown to become the market leader in solid support in the oligonucleotide synthesis field. We are bringing the most creative minds in science and technology to develop medical discoveries and breakthroughs. Our customers are well-known in the biotechnology industry. We are in a growth phase within ISO work environment and leading towards a GMP Certification. KLS is seeking extraordinary people to join the team.

Why Work Here?

Great place to work. Small subsidiary of large international company headquartered in Japan. Generous discretionary bonuses!

JOB SUMMARY:

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 and possesses the ability to follow directions exactly as given and be capable of working with limited supervision. Ability to write and review SOP and reports is highly desirable.

ESSENTIAL DUTIES and/or 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.

MINIMUM EDUCATION and/or EXPERIENCE:

• 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 DEMANDS and/or WORK ENVIRONMENT:

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.

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