QC Sample Management Senior
Posted on: November 22, 2022
POSITION OVERVIEW Department : The Quality Control Sample
Management (QCSM) group supports the Quality Control (QC)
Organization at Framingham Biologics. QC Sample Management is
responsible for Sample Receipt of QC samples, chain of custody
requirements, retains and reserves, verification of the accuracy of
the materials submitted and entry and receipt into the various
digital system and business tools that support QC operations. This
includes supporting the QC Laboratories across the Framingham
Campus and coordinate shipment of testing samples to contact
testing sites. Sample Management aims to provide timely and
dependable operational support to the QC Chemistry, QC Microbiology
and QC Biopolymers groups on a daily basis to ensure timely and
right the first time delivery of test results required by
Manufacturing Operations groups and Quality Assurance. This
position is Wednesday to Saturday shift, 8:30 AM to 7:00 PM Key
Responsibilities may differ among employees with the same job title
and may change over time in accordance with business needs. This is
a fast paced, highly complex environment, where individuals will be
- Coordinate distribution of samples to other laboratories and
sample requiring send out, domestic and international, maintain
chain of custody.
- Mentor and train laboratory coordinators, maintains
- Identify and investigate departures from QC procedures,
provides guidance to more junior staff.
- Recommend improvements, manages CAPAs.
- Review data entry and logbooks for compliance to
- Order of laboratory supplies, including Capital expenditures
and monitor standing purchase orders.
- Manage laboratory reserve samples, provides oversight of
discards, coordinate and schedule annual inspections.
- Attends meetings as department representative or delegate.
- Schedule major activities within Sample management. Provide
technical leadership and guidance for the successful completion of
major laboratory projects:
- Subject matter expert for Sample Management, interacts with
auditors during inspections, maintains inspection readiness.
- Develop complex and explicit documentation to implement new
procedures, performs periodic review of current procedures.
- Implement and monitor personnel training.
- Work effectively with others to achieve shared goals.
- Effectively demonstrated competency of CGMPs and Data integrity
practices, promotes compliance culture.
- Communicates effectively cross-functionally and escalates
- Works independently with minimal supervision, must have
demonstrated ability to make decision using critical thinking and
problem solving and provide guidance to staff. This includes during
non-standard hours when management is not on-site.
- Practices safe work habits and helps to promote safety
procedures and guidelines. Basic Qualifications:
- High School Diploma with minimum of 8 Years of relevant
industry experience or an equivalent combination of education and
experience may substitute.
- Previous experience in Sample Management or a GMP role
- Critical thinking and problem-solving skills.
- Excellent interpersonal and communication skills
- Demonstrated competency of CGMPs and Data integrity
- Proficient with Microsoft Office tools such as: Word, Excel
Outlook & PowerPoint
- Experience with Laboratory Information System (LiMS)
- Strong attention to detail and demonstrated organizational
skills due to the complexity of the samples received and systems
- Ability to adapt and adjust to changing priorities and to
manage assignments with challenging/conflicting deadlines due to
expiry and delivery timelines
- Ability to work in a high-paced team environment and meet
- Ability to communicate effectively with peers and department
management S pecial Working Conditions:
- Must be able to lift 40 lbs.
- Must be able to work with Spor-klenz solution, which is used to
sanitize equipment following SOP guidelines.
- Position is considered essential personnel and may be required
to staff the lab during inclement weather events 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. 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+
students, inclusive employers & anyone who believes in workplace
Keywords: myGwork, Framingham , QC Sample Management Senior, Executive , Framingham, Massachusetts
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