QA Associate II

Job Locations US-MA-Bedford
Posted Date 2 months ago(6/3/2022 8:52 AM)
Job ID
2022-1587
# of Openings
1
Category
Quality

Overview

The QA Associate II will work in collaboration with all departments within Ocular, to provide the necessary QA support needed to ensure all documentation associated with the production of commercial product is in compliance with approved internal procedures and specifications, as well as compliant with all applicable regulations. 

Additionally, they will be expected to review, monitor, inspect and propose measures to correct or improve product quality and current Quality processes as well as ensure compliance to internal procedures and external standards and regulations. The QA Associate II will also be responsible for quality oversight and phase-appropriate cGMP guidance throughout the product lifecycle.

Responsibilities

  • Review documentation supporting GMP activities for accuracy and completeness such as batch record review and disposition (commercial and clinical) as well as QC data review
  • Conduct batch record reviews as well as release all commercial and clinical batches for distribution
  • Review and improve quality system procedures (SOPs), specifications, and test methods
  • Perform quality related activities as required within the various Quality Systems including Change Control, Deviation Reporting, CAPA, and Product Complaint Handling
  • Participate on project teams as the QA representative
  • Coordinate or perform investigations of quality issues and product complaints and implement corrective/preventive actions
  • Train other staff, if needed, after being approved as a Qualified Instructor (QI) for Quality Systems
  • Review and approve calibration documentation.
  • Review equipment/system work orders on electronic asset manager.
  • Review and assess out-of-tolerance notifications and unscheduled maintenance work orders for impact on product, validation, calibration.
  • Support Annual Product Review (APR) Reports and analyze data to ensure control of process.
  • Perform risk assessments (Risk Analysis, FMEA, PFMEA).
  • Participate in site inspections and compliance decisions presented to regulatory agencies and other 3rd Party audits.
  • Perform other quality assurance duties as assigned

Qualifications

  • Bachelor’s degree in relevant scientific discipline
  • Minimum three years of experience in pharmaceutical, biotech or medical device industry
  • Excellent organizational skills and attention to detail
  • Good verbal and written communication skills
  • Strong interpersonal skills and ability to work efficiently on a team
  • Computer literacy, proficiency in MS Office, Excel, PowerPoint etc.
  • Ability to make decisions and resolve issues with minimal guidance
  • Knowledge of FDA and international regulations and GxP guidelines

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