QC Analyst II

Company: myGwork
Location: Framingham
Posted on: August 4, 2022

Job Description:

POSITION OVERVIEW Job Description: The Quality Control department supports the Seprafilm (medical device) and Sodium Hyaluronate (active pharmaceutical ingredient) GMP operations at the 74/76 NYA Manufacturing Facility. The department performs analytical testing on intermediate, in-process and final product materials using a variety of equipment to include GC, FTIR, UV VIS, and physical property instrumentation. Position Summary

• Supports Biosurgery Business by performing in-process, stability, and release testing for
• Biosurgery Product lines.
• Core Responsibilities
• Perform Assays in accordance with SOPs for release, stability, and in-process samples.
• Review peer data including data transcription, data calculation, and log entries.
• Lab general duties include cleaning, glassware, washing, etc.
• Initiate DCR when assigned.
• Train on all documents assigned to a training plan and complete training as assigned.
• Receive, verify and log incoming samples.
• Perform or participate in Equipment Qualifications.
• Perform or participate in Method Validations.
• Participate in audits.
• Complete training as assigned.
• Author technical reports.
• Bring in new equipment (spec, URS, etc.)
• Perform PM or calibration on lab equipment.
• Conduct safety and weekly compliance walkthroughs.
• Responsible for adherence to policies, procedures, and SOPs.
• Participate in Lab Investigations.
• Perform OOS investigations as an Analyst.
• Adhere to Site Quality and Safety Policies.
• Work toward the accomplishment of Site Goals.
• Initiate and help investigate deviations through Trackwise.
• QC testing of in-process, stability, and release samples in a GMP lab.
• Troubleshooting of assay/equipment issues.
• Coordinator Roles that may be assigned:
  • Metrology
  • Purchasing
  • Documentation
  • CSO
  • Safety
  • Assay occasion tracking
  • Logs
  • Reserves
  • Product Point of Contact
  • Data Back-Up **1st shift- Monday-Friday- flexible start/end time BASIC QUALIFICATIONS
    • Bachelor's degree in Life Sciences or equivalent (Chem, Bio, Microbio, etc)
    • Minimum of 2 years of laboratory experience. PREFERRED QUALIFICATIONS
      • Experience in laboratory techniques such as pH, GC, UV/VIS, and FTIR.
      • Experience in GMP laboratory as well as technical writing.
      • Strong attention to detail and ability to multitask. SPECIAL WORKING CONDITIONS
        • Requires working with hazardous chemicals. As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. Fully vaccinated, according to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. This employer is a corporate member of
          myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals,
          students, inclusive employers & anyone who believes in workplace equality.
          

Keywords: myGwork, Framingham , QC Analyst II, Professions , Framingham, Massachusetts