Advantage Technical
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Job Title: Tech Ops & Quality – Quality Control Analyst II Reason for Hire:
Increased activity
Location:
Norton, MA
Training:
Initial Monday–Friday training
Job Summary The Quality Control Operations (QCO) Analyst II (Contractor) supports the maintenance of high standards of quality and compliance from development through commercialization. This role includes performing routine and non‑routine testing, contributing to data trending and investigations, supporting laboratory operations, and assisting with method transfers, qualification/validation, verification, and implementation. The position plays a key role in enhancing QC efficiency and effectiveness.
This is an onsite position based in Norton, MA, with occasional responsibilities at other Alnylam locations.
Key Responsibilities Laboratory Testing & Operations Perform routine and non‑routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in‑process samples, product release, and stability studies in accordance with SOPs Support weekend laboratory operations and maintain required training records Assist with laboratory equipment and inventory maintenance, including reagent and sample preparation Perform operational tasks such as raw material processing, environmental monitoring, and in‑process testing
Data Review & Documentation Review data in a timely manner and serve as a qualified data reviewer Contribute to the creation and revision of controlled documents, including SOPs, work instructions, and test methods Follow internal policies, SOPs, and applicable regulatory standards (GMP, GLP, ICH)
Quality & Compliance Support Participate in continuous improvement initiatives and cross‑functional collaboration Support regulatory submissions, inspection readiness, and audits
Qualifications Education & Experience Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related field 4–8 years of pharmaceutical or biotech experience in GMP QC or equivalent environments Experience with method transfer and implementation; understanding of method lifecycle management preferred Strong technical writing, data analysis, problem‑solving, and organizational skills Excellent communication and teamwork abilities Proficiency in LabWare LIMS, Microsoft Excel, Word, and PowerPoint preferred
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Job Title: Tech Ops & Quality – Quality Control Analyst II Reason for Hire:
Increased activity
Location:
Norton, MA
Training:
Initial Monday–Friday training
Job Summary The Quality Control Operations (QCO) Analyst II (Contractor) supports the maintenance of high standards of quality and compliance from development through commercialization. This role includes performing routine and non‑routine testing, contributing to data trending and investigations, supporting laboratory operations, and assisting with method transfers, qualification/validation, verification, and implementation. The position plays a key role in enhancing QC efficiency and effectiveness.
This is an onsite position based in Norton, MA, with occasional responsibilities at other Alnylam locations.
Key Responsibilities Laboratory Testing & Operations Perform routine and non‑routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in‑process samples, product release, and stability studies in accordance with SOPs Support weekend laboratory operations and maintain required training records Assist with laboratory equipment and inventory maintenance, including reagent and sample preparation Perform operational tasks such as raw material processing, environmental monitoring, and in‑process testing
Data Review & Documentation Review data in a timely manner and serve as a qualified data reviewer Contribute to the creation and revision of controlled documents, including SOPs, work instructions, and test methods Follow internal policies, SOPs, and applicable regulatory standards (GMP, GLP, ICH)
Quality & Compliance Support Participate in continuous improvement initiatives and cross‑functional collaboration Support regulatory submissions, inspection readiness, and audits
Qualifications Education & Experience Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related field 4–8 years of pharmaceutical or biotech experience in GMP QC or equivalent environments Experience with method transfer and implementation; understanding of method lifecycle management preferred Strong technical writing, data analysis, problem‑solving, and organizational skills Excellent communication and teamwork abilities Proficiency in LabWare LIMS, Microsoft Excel, Word, and PowerPoint preferred
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