Quality Control
North, MA
il y a 2j

QC Data Reviewer

QC Compliance Specialist Under the direction of the Quality Control Management, the QC Compliance Specialist will be responsible for ensuring and enforcing group compliance to all laboratory, documentation, procedural and regulatory requirements.

The QC Compliance Specialist will also be responsible for supporting various analysts in QC documentation roles.

Responsibilities will include, but are not limited to, the following :

  • Be part of a team of analysts who are responsible for all aspects of laboratory data review (technical and compliance), authoring laboratory investigations and certificates of analysis
  • Assist in ensuring 100% inspection readiness
  • Responsible for trending OOS, OOT and invalids and implementing process improvements
  • Monitor and ensure timely closure of all laboratory investigations, OOS, OOT, invalids and CAPA's
  • Assist in the monitoring of deliverables for batch release and stability are met
  • Assist in driving process improvement projects for the QC lab and organization
  • Review investigations, specifications and other GMP documentation
  • Qualifications Education & Certifications

  • BS degree in the life or physical sciences with a preference for a concentration in microbiology, analytical chemistry or pharmaceutical chemistry.
  • Minimum of 3 years' experience working in a GMP laboratory
  • Experience with Waters Empower Software and TrackWise preferred
  • Thorough understanding of cGMP's and good documentation practices
  • Ability to work with minimal supervision as well as in a team environment
  • Strong organizational and presentation skills
  • Strong relationship, teambuilding, customer-focused orientation coupled with the ability to deliver results and meet or exceed agreed-upon objectives and timeframes :
  • Ability to handle multiple priorities.
  • Ability to work under time and resource constraints.
  • Commitment to excellence and high standards. Communication & Interpersonal Skills
  • Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

    Company Profile :

    Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

    Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties / disciplines and industries.

    Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

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