Kinovate Life Sciences | Oceanside, CA

HR Systems Analyst

Job details

Pay
$80,000 - $90,000 a year
Job type
Full-time
Shift and schedule
Monday to Friday

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 or identified

MINIMUM EDUCATION and/or EXPERIENCE:

  • 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.

Required Skills, Experience, and Education:

  • Proficient in Identifying and resolving problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; and uses solid reasoning.
  • Proficient in understanding and interpreting Federal, State, and local employment laws; foreign labor law, a plus.
  • Proven ability to manage change in a complex and often challenging manufacturing environment.
  • Ability to prioritize and plan work functions; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks, if needed; and develops realistic action plans.
  • Strong organizational skills, flexibility in responding to rapidly changing, dynamic processes and demands/pressures in a fast-paced environment.
  • Advanced Microsoft Office Suite software applications such as Excel, Word, Power Point, and other enterprise software applications such as HRIS, Applicant Tracking, Performance Management and Payroll systems.
  • Strong verbal and written communication skills. Strong interpersonal skills to work across organizational groups, with the proven ability to build effective relationships with a diverse range of people, including building partnerships to coach management and employees. Ability to present moderately complex issues to groups or individuals.
  • Provide high-level customer service and conflict resolution skills, with an emphasis on team building.
  • Sustain current knowledge and new developments in the field with day-to-day application of subject matter and ongoing willingness to attend seminars as necessary.
  • Working knowledge of social media applications, HRIS and/or Applicant Tracking Systems.
  • Bilingual or Multi-lingual in languages frequently used within the Nitto Group of Companies, a plus.

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.

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