Quality Control Specialist - Biotech Life Science at YOH Services LLC in Oceanside, California

Job Description:

Yoh is a seeking a Quality Control Specialist II to support a San Diego based company in the biotechnology industry, who is the leader in high performance, high quality polymeric solid support for the synthesis of therapeutic oligonucleotide market. They are providing the highest quality materials to niche life science markets.

Title: Quality Control Specialist II

Location: San Diego Area - Oceanside

Type: Direct Hire

Pay: Competitve

Industry: Biotechnology

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 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

Required Skills, Experience, and Education:

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  • 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:

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  • 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 Job Requirements:

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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Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.