Quality Control Specialist II

Job details

Pay

$32 - $37 an hour

Job type

Full-time

Shift and schedule

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. KLS is proud to be an equal employment opportunity employer.

Why Work Here?

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

JOB SUMMARY:

The successful candidate in this position is responsible for: chemical and chromatographic analyses of incoming raw material, in-process samples and final products; raw material and finished product release; stability coordination and testing; and method development, feasibility, validation, and transfer as well as drafting associated protocols and reports.

ESSENTIAL DUTIES and/or RESPONSIBILITIES:

• Control of raw materials
• Testing of raw material, in-process samples, finished products, and stability samples as well as completion of associated QC documentation. QC analyses include: Gas Chromatography (GC), Liquid Chromatography (LC), Mass Spectrometry (MS), Karl Fischer titration (KF), Ultraviolet-Visual Spectroscopy (UV/Vis), and miscellaneous wet chemistry lab work.
• Review of QC analytical data as well as comprehensive analytical records.
• Maintain, revise, and implement cGMP procedures as necessary for Quality Control (SOP’s, analytical test methods, forms, specifications, etc.)
• Maintaining cGMP quality level of work.
• Independently handling quality excursions such as deviations
• Developing analytical test methods for raw materials and finished products.
• Drafting and review of validation protocols for analytical methods as well as cleaning methods.
• Providing analytical support in regards to customer needs/concerns.
• Develop, optimize, and qualify/validate various analytical methods.
• Other duties as assigned.

REQUIRED SKILLS, EXPERIENCE and EDUCATION:

• BS in Chemistry or related field
• Minimum of 2 years’ experience in a GMP environment
• Experience with the use of analytical techniques/instruments such as GC, LC, MS, UV/Vis, KF, etc.
• Minimum 2 years of work experience in quantitative analysis of organic compounds. New graduates with undergraduate research experience and excellent academic records will be considered.
• Capable of or eager to learn designing method development experiments and writing protocols and reports.
• Excellent team skills, effective organization, and presentation skills
• Ability to work independently and effectively under minimal supervision.
• Ability to effectively work in a fast-paced work environment.
• Excellent problem solving and planning skills.
• Detail oriented with the ability to troubleshoot and resolve issues.
• Proficiency in Microsoft Word, PowerPoint, Access, and Excel.

DESIRED SKILLS and EXPERIENCE:

• Strong understanding of compendial/regulatory requirements (i.e. ISO 9001, USP, cGMP, ICH Q7).
• Prior experience in the development and validation of analytical test methods, especially with respect to chromatographic test methods.
• Prior experience managing stability studies.

PHYSICAL DEMANDS and/or WORK ENVIRONMENT:

Office/Lab environment. Lifting up to 30 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, reach with hands.

Apply on Indeed