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Randstad QC Analyst in Lexington, Massachusetts

QC Analyst

job details:

  • location:Lexington, MA

  • salary:$35.23 - $41.45 per hour

  • date posted:Wednesday, May 19, 2021

  • experience:3 Years

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:36527

job description

QC Analyst

job summary:

As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

location: Lexington, Massachusetts

job type: Contract

salary: $35.23 - 41.45 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

Primary duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations/validation or development studies.

Testing may include but not limited to samples from in process, drug substance/product and various protocol studies using analytical test methods derived from non-compendial sources.

The position is expected to maintain operational and GMP readiness of the QC area. In addition, the individual will participate in more complex projects, operational excellence initiatives including 5S/lean improvements, method/equipment validation, method transfer and various quality systems (deviations, change controls, investigations) with little to no supervision, and maybe asked to take lead roles for the QC organization on these projects.

Position is expected to act as a role model for junior staff in the various QC areas.

Specific HPLC Focus Areas:

Role is responsible for HPLC laboratories performing a broad range of analytical based techniques such as SE-HPLC, RP-HPLC, IEX, CE-SDS, glycan and peptide analyses in order to support in-process, release and stability testing.

Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected.

Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.

Specific QC Focus Area:

Product testing: Areas of focus on techniques such as HPLC and SDS-PAGE for purity, identity, potency and charged heterogeneity.

  • Perform and troubleshoot HPLC based assays (SE-HPLC, IEX, RP-HPLC, CE-SDS, Peptide Mapping, and Glycan Mapping) of release and stability

  • Review QC analytical assays

  • Execute and lead method qualification and validation assays as needed

  • Perform and lead OOT, OOS, GMP Investigations, data analysis, deviation and data trending

  • Maintain GMP condition of the lab

qualifications:

Typically requires a bachelor's degree and a minimum of 2+ years of related experience. (science related degree is preferred)

skills: HPLC, Assay Development

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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