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QC Analyst III
The Quality Control Analyst III – Chemistry, will be responsible for performing analytical testing for the portfolio of pre-clinical, clinical, and commercial programs at our client. This role will support both Alewife and Norton Manufacturing facilities with occasional support at Kendall on an as-needed basis. Phase appropriate method implementation and/or method transfer/validation understanding as well as Empower experience is desirable. The position requires flexibility with changing priorities.
Summary of Key Responsibilities
Demonstrated knowledge of analytical testing (U/HPLC, LC-MS, GC, KF, spectroscopy, 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 issues.
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 company electronic management system driving and supporting completion of formal root cause analyses, deviations, change control, CAPA and effectiveness checks.
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 desired.
Ability to travel between domestic sites is required (Norton, MA; Cambridge, MA).
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.