Quality Control Analyst III
Company: Yoh, A Day & Zimmermann Company
Posted on: April 10, 2021
**Ability to travel between Norton, MA and Cambridge, MA
Summary of Key Responsibilities
Performance of moderate to complex QC testing for raw material,
in-process, release, and stability in accordance with turn-around
time requirements and KPI.
May support raw material testing, inspection, and release
Demonstrated knowledge of analytical testing (U/HPLC, LC-MS, GC,
etc.) to support method implementation and routine testing.
Leads phase appropriate technology transfer, feasibility, method
transfer, and method validation.
Assist in the support and management of laboratory equipment
lifecycle management by implementing new technology/instrumentation
in the QC laboratory and ensuring existing instrumentation are
maintained to standard.
Peer review data related to testing and laboratory operations
(i.e., investigations, equipment qualifications, etc.).
Author and review technical documentation (e.g. SOPs, protocols,
reports) with guidance commensurate with experience.
Troubleshoot routine problems related to laboratory procedures,
assay performance, instrumentation, and data with guidance
commensurate with level; provide recommendations to non-routine
Contribute substantially to interpretation of data including
trending of analyses, investigations (OOS, atypical, out of trend,
MDN), and design of experimentation.
Conduct and support investigations and changes through the Alnylam
electronic management system driving and supporting completion of
formal root cause analyses, deviations, change control, CAPA and
Conduct and support continuous improvement efforts of operation
systems (i.e., automation, efficiency, reduction of waste)
Ensures continuous GMP-compliant state of the QC laboratories. May
participate in audit and inspection activities.
Collaborate with internal departments efficiently and effectively
(e.g. Manufacturing, Quality Assurance, Process Sciences,
Analytical Sciences, and Regulatory Affairs)
Promote Safe, positive, and compliance-driven work environment
Minimum education required for this position is a Bachelor of
Science Degree in a scientific discipline (e.g. Analytical
Chemistry, Biochemistry, Chemistry, Biology, etc.).
Minimum experience required for this position is 4-6 years of
experience in a GMP laboratory.
Experience with QC analytical testing platforms (U/HPLC on Empower,
LC-MS, GC, Karl Fisher, ICP-OES, spectroscopy, etc.); raw materials
(sampling/testing) experience and microbiology experience desirable
but not required.
Knowledge of and ability to interpret USP, Ph. EUR, JP, and ICH
guidelines is desirable
Experience with laboratory equipment lifecycle management processes
for URS and IQ/OQ/PQ required; familiarity with data integrity and
laboratory software validation is desired.
Experience/Familiarity with LIMS, in particular LabWare LIMS, is
Ability to travel between domestic sites is required (Norton, MA;
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, disability, or status as a
protected veteran. Visit
https://www.yoh.com/applicants-with-disabilities to contact us if
you are an individual with a disability and require accommodation
in the application process.PandoLogic.Category: Quality Control,
Keywords: Quality Control / Quality Assurance Analyst
Keywords: Yoh, A Day & Zimmermann Company, Brookline , Quality Control Analyst III, Professions , Brookline, Massachusetts
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