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Quality Assurance Analyst

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Bio-Techne

2mo ago

  • Job
    Full-time
    Junior & Mid Level
  • Science
  • Wallingford
  • Quick Apply

AI generated summary

  • You need a relevant degree with experience in quality roles, strong analytical and Excel skills, knowledge of quality regulations, and attention to detail. Immunoassay experience is a plus.
  • You will manage and interpret biological data, ensure product quality, support investigations, recommend improvements, maintain records, present data, perform lab tasks, and assist in new product launches.

Requirements

  • Bachelor’s degree in biology, Chemistry or Engineering with 2+ years’ experience.
  • Non-scientific bachelor’s degree with 4+ years’ experience working in a quality position for a GMP or life science related 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.

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, like Simple Plex consumables, as needed

FAQs

What is the primary responsibility of a Quality Assurance Analyst at Bio-Techne?

The primary responsibility of a Quality Assurance Analyst at Bio-Techne is to plan, execute, and manage activities in the Simple Plex cartridges QC process to ensure that all objectives are met and that the product functions as expected.

What kind of educational background is required for this position?

A Bachelor's degree in biology, chemistry, or engineering with 2+ years of experience is required, or a non-scientific bachelor's degree with 4+ years of experience working in a quality position in a GMP or life science-related industry.

What skills are essential for success in this role?

Essential skills include outstanding analytical abilities, proficiency in Excel and Microsoft Windows, the ability to evaluate large data volumes quickly, a strong understanding of quality system regulations, and experience in an ISO-compliant or regulated environment.

Will I need to perform lab work in this position?

Yes, the role may require performing lab work, including the preparation of controls and reagents and conducting instrument runs as needed.

Are there opportunities for career development at Bio-Techne?

Yes, Bio-Techne offers mentorship, promotional opportunities, training and development initiatives, and internship programs to help employees develop their careers.

How does Bio-Techne support work-life balance?

Bio-Techne supports work-life balance by offering competitive wages, extensive benefits, and fostering a culture of caring and belonging through various employee resource groups and events.

What types of investigations will I support in this role?

You will support deviation and out-of-specification investigations and provide recommendations for corrective actions.

Is experience in immunoassay methodology necessary for this position?

Experience with immunoassay methodology is a plus, but it is not explicitly required for the position.

How does Bio-Techne ensure a diverse work environment?

Bio-Techne fosters a diverse work environment by offering employee resource groups, volunteer events, and activities that promote a culture of caring and belonging.

What kind of data management is expected in this role?

The role includes compiling, documenting, interpreting, and managing biological data to evaluate the quality of in-process materials and finished goods and curating that data into a LIMS database.

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Bio-Techne

Science & Healthcare
Industry
1001-5000
Employees

Mission & Purpose

Bio-Techne Corporation (NASDAQ: TECH) is a leading developer and manufacturer of high-quality purified proteins and reagent solutions - notably cytokines and growth factors, antibodies, immunoassays, biologically active small molecule compounds, tissue culture reagents, and cell and gene therapy workflow solutions including T-Cell activation technologies. Bio-Techne’s portfolio also includes protein analysis solutions, sold under the ProteinSimple brand name, that offer researchers efficient and streamlined options for automated Western blot and multiplexed ELISA workflow. These reagent and protein analysis solutions are sold to biomedical researchers, as well as clinical research laboratories, and constitute the Protein Sciences Segment. Bio-Techne also develops and manufactures diagnostic products including FDA-regulated controls, calibrators, blood gas and clinical chemistry controls, and other reagents for OEM and clinical customers. Bio-Techne’s genomic tools include advanced tissue-based in situ hybridization assays (ISH) for research and clinical use, sold under the ACD brand, as well as a portfolio of clinical molecular diagnostic oncology assays including the ExoDx®Prostate (IntelliScore) test (EPI) for prostate cancer diagnosis. These diagnostic and genomic products comprise Bio-Techne’s Diagnostics and Genomics Segment. Bio-Techne products are integral components of scientific investigations into biological processes and molecular diagnostics, revealing the nature, diagnosis, etiology and progression of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $714 million in net sales in fiscal 2019 and has over 2,200 employees worldwide.