Quality Control

  • location: Cambridge, MA
  • type: Contract
  • salary: $45 - $49.32 per hour
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job description

Quality Control

Job Title: Quality Control Analyst II

Position Description

  • Provide analytical support for product complaint investigations
  • Providing analytical support during the technology transfer and qualification of new manufacturing sites
  • Managing contract testing sites (both domestic and international) to support testing of the IPC, release and stability samples
  • Performing data review, data tracking and trending to support release and stability testing of drug products
  • Supporting regulatory submissions by providing batch analysis and stability testing data
  • Representing QC business processes and needs within the department and at cross functional forums
  • Independently support a range of assigned projects, routine, non-routine, and investigative QC laboratory analytical testing pertaining to, commercial release testing, process validation, stability, and performance trending to support drug substance and drug product and/or finished goods
  • Support quality control CMC regulatory activities
Position Responsibilities

  • Demonstrates an understanding of company priorities, objectives and project timelines. This includes understanding how QC activities affect the business.
  • Applies scientific judgment to perform investigations of Out of Spec (OOS) and Atypical results. Works with external service providers on the timely resolution of deviations.
  • Collaborates with Regulatory Affairs on preparation of submission documents, responses to questions from Health Authorities, and updates on stability and batch analysis data.
  • Supports and oversees testing for process validation activities, as applicable.
  • Authors stability protocols and reports, validation documentation, change controls and investigations to maintain compliance.
  • Demonstrates good understanding of analytical methodology.
  • Ensures that complete, accurate and valid quality testing documentation is received by Company.
  • Meets with multifunctional groups on a regular basis to discuss individual projects and departmental goals.
  • Actively engage fellow analysts and specialists as a peer coach, offer/seek perspective and guidance
  • Generate notification forms indicating investigation activities such as retain inspection, and analytical testing as appropriate for Product Complaints
  • Retain Testing at Contract Manufacturers/Laboratories
  • May perform other duties as assigned.
Position Requirements

  • Bachelors or Masters Degree in Life Sciences (chemistry or biology) with relevant laboratory coursework and 3-6 years of experience in Pharmaceutical/Biotechnology field
  • Must have good understanding of a variety of analytical techniques such as HPLC, GC, CE-SDS, bioassay and icIEF. Experience in cell based assays and oral solid dosage is a plus.
  • Must have good understanding of cGMPs and quality systems.
  • Ability to handle multiple tasks concurrently, and in a timely fashion, organizational skills and attention to details.
  • Must have good communication and interpersonal skills and ability to work effectively and efficiently in a team environment.
  • Must be computer literate and able to navigate, conduct searches, and complete online forms for the purposes of training, performance management, and self service applications.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
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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