• Job Description

  Req#: 24-41101
  *The position will onboard in January
  Hybrid Role
  The Requirements for this position is:
  • Bachelor’s and/or 8+ years of relevant experience
  • Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences)
  • Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
  • Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
  • Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
  • Preferred experience with outsourced manufacturing and testing operations
  • Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
  This role will be:
  • Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials
  • Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
  • Ensure that all requirements, as stipulated in the appropriate QTA, have been met.
  • Issue/Review documentation, i.e. Deviations, CAPAs, OOS (out of spec) etc., as they occur.
  • Write and revise SOP, forms, WI, and any other document types
  • Assist with internal and external audits.
  • Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
  • Assume additional responsibilities as assigned.
  
  EEO:
  
  “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

• About the company

  Mindlance is one of the largest diversity-owned staffing firms in the US . As a recruitment centric talent acquisition company, Mindlance provides Technology, Engineering, Digital / Creative / Marketing, Clinical Research, Scientific, Finance, Professional and Payroll Management staffing services to Global 1000 companies across the US, Canada and India.

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