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
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