Connecting...

W1siziisijiwmtkvmdevmtcvmdkvntkvndmvmtu0l2vuz2luzwvyaw5nmi5qcgcixsxbinailcj0ahvtyiisijiwmdb4nzawiyjdxq
Job

Quality Analytical Analyst.

  • Job ref:

    11202

  • Location:

    Wallingford, United States

  • Sector:

    Pharmaceutical

  • Contact:

    Dan Dubay

  • Published:

    over 1 year ago

  • Consultant:

    #

Job Description

For almost 50 years, Lighthouse Professional Services has worked to provide full-service consulting and staffing partnerships to clients in Connecticut, Massachusetts, Rhode Island, New Hampshire, and the Carolinas. Our innovative solutions can reach all areas within your firm including: Administrative, Information Technology, Engineering, Finance, Clerical and Light Industrial.

Lighthouse Professional Services committed to the success of the companies, candidates and employees we serve. We invest in excellent working partnerships, powered by people.

We are currently seeking a Quality Control Analyst in Wallingford, CT.

Position Summary and Special Duties:

As a (an) Quality Control Analyst your day to day duties will consist of and may not be limited to:

Position Summary:

Reporting to the Quality Supervisor, this person will be responsible for planning, executing, and managing activities in the consumables QC process to ensure that all applicable objectives are met, and the product functions as expected. To be successful in this role candidate needs to be skilled in analytical techniques for analysis of biological assays. This position interfaces with Manufacturing, Process Engineering, Product Support, Assay Development and Quality Assurance. 

Key Responsibilities:

  • Compile, document, interpret and manage biological data to evaluate the quality of in-process materials and finished goods to either confirm compliance with established quality standards or identify deviations. This includes functional, assay performance, precision, and accuracy testing.  Data management comprises analysis and disposition of data produced and curation of that data into a LIMS database.
  • Ensure that the final product satisfies the product requirements and meet end-user expectations 
  • Support deviation and out-of-specification investigations
  • Provide recommendations for corrective actions
  • Spot areas for improvement to enhance the product's efficiency
  • Maintain clear and accurate records
  • Attend cross-functional team meeting and present data summaries
  • Perform lab work when needed, including preparation of controls and reagents, and performing instrument runs
  • Support new product launch activities
  • May be responsible for establishing specifications and writing standard operating procedures
  • Support other QC operations as needed

Qualifications

Education and Experience:

  • Bachelor's degree in a scientific discipline, biomedical engineering, or informatics with 4+ years of related experience, preferably within the life science, biotech, or medical device industry.
  • Outstanding analytical skills. R Analysis experience a plus.
  • Super user level in Excel and proficient in all Microsoft Windows functions
  • Ability to evaluate large volumes of data in a short timeframe
  • Strong understanding of quality system regulations and standards
  • Experience working within an ISO compliant, or other regulated environment.
  • Experience developing, reviewing, deploying Standard Work (WI’s, MI’s, SOPs)
  • Strong presentation skills
  • Experience with immunoassay methodology a plus
  • Demonstrated ability to deliver quality work, with high work accuracy.
  • Demonstrated ability to meet project timelines and collaborate with internal team
  • Organized with exquisite attention to detail
  • Duration: Direct hire
  • Location: Wallingford, CT.
  • Salary: depending on experience
  • Benefits: yes
     

Qualified candidates are encouraged to apply immediately!

Please include a clean copy of your resume and salary expectations and any references.

Submit resumes to: dan.dubay@lighthousproefessional.com