Senior Quality Control Analyst

4 weeks ago


Philadelphia, United States R&D Partners Full time
Job DescriptionJob Description

Essential Functions and Responsibilities

  • Supports Technology Transfer related to new validated assays or process improvements to internal and external laboratory facilities. Provide hands-on technical training to laboratory personnel as part of process tech transfer as needed.
  • Supports Stability Program, data review, protocol and report writing.
  • Translate validation reports into technical test methods and SOPs as part of
  • tech transfers. Will assist QC and QA when authoring Test Methods and implementing process improvements.
  • Observe and provide feedback of Quality Control technical operations, ensure alignment of Quality Control technical laboratory practices across multiple facilities.
  • The Specialists may be responsible to support the authoring documentation such as Impact and Risk Assessments and Failure Modes Risk Analysis.
  • Analyze and interpret technical laboratory data. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the laboratory operations environment.
  • Support GMP investigations for out of specification test results and corrective actions
  • Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed.
  • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
  • Due to the nature of testing schedules, must be willing to work weekends, evenings, and holidays, as needed.

 

Required Education, Skills, and Knowledge

  • Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
  • Minimum 5 years of experience in the biopharmaceutical industry within a Quality Control role
  • Solid understanding and functional knowledge with hands-on experience with Cell base Assays, cell culture (primary cells and cell lines),
  • Proficient in performing technical writing (e.g., test methods, SOPs, protocols, etc.)

 

Preferred Education, Skills, and Knowledge

 

  • Experience with cell and/or gene therapy products is a plus
  • ELISA, Flow Cytometry, etc,

 

Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.

The cornerstone of our success: a knowledgeable and experienced recruiting team.

Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.\r
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The cornerstone of our success: a knowledgeable and experienced recruiting team.\r
\r
Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.

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