QC Analyst II at Flexion in Burlington, MA

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Description

We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough.

Our values - focus, ingenuity, tenacity, transparency and fun - form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.
Sound good so far? It really is!

The Role:

Flexion has a new position for a Quality Control Analyst II. The role includes planning, coordinating, and managing outsourced Quality Control activities with contract test laboratories and/or contract manufacturing sites. The QC Analyst II will provide technical support for the contract lab/CMO and ensure that all testing, deviations, and investigation resolutions (e.g. OOS) are performed at a high quality, in a timely manner, and in line with Flexion SOP's and quality agreements. Additionally, the role will be responsible for performing data trending in support of stability studies, investigations, risk assessments, and regulatory filings.

Responsibilities:

  • Manage cGMP in-process, release, and stability testing performed at contract testing laboratories/CMOs
  • Review lab data generated by contract test laboratories/CMOs
  • Provide data trending analysis (JMP experience preferred) in support of stability studies, investigations, risk assessments, Annual Product Quality Review, and Regulatory filings
  • Prepare Certificates of Analysis to support batch disposition
  • Author and review QC SOPs, protocols and reports
  • Author technical reports and sections for regulatory submissions
  • Work cross functionally to coordinate sample shipments and testing timelines
  • Author and review deviations, change controls, CAPAs, OOT/OOS
  • Lead the transfer of analytical methods between contract laboratories
  • Interact closely with peers in Analytical Development, CMC, QA, Supply Chain, & Regulatory

BasicRequirements:

  • BS in a scientific discipline, with a minimum of three (3) years of related QC experience
  • Strong knowledge of cGMP/ICH/FDA/EU regulations as applied to quality control laboratories
  • Domestic & International travel required (approximately 5%)

Preferred Requirements:

  • Independently motivated and detail oriented with good problem-solving ability
  • Excellent organizational skills, with the ability to multi-task in a fast-paced environment with changing priorities
  • Strong working knowledge of chemistry and microbiological methodologies (experience working in a GMP laboratory a plus)
  • Experience with late phase/commercial products preferred


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