Tech Ops and Quality - Quality Control Analyst II

TalentBurst•Norton, MA

5h•Onsite

About The Position

The Quality Control Operations (QCO) Analyst II Contractor supports maintaining high standards of quality and compliance from development through commercialization. The role includes performing routine and non-routine testing, participating in data trending, investigations, and lab operations, and supporting method transfers, qualification/validation, verification, and implementation. This position enhances QC efficiency and effectiveness.

Requirements

B.S. in chemistry, biology, biochemistry, or related field
4-8 years of pharmaceutical/biotech experience in GMP QC or equivalent
Experience in method transfer/implementation; understanding of method lifecycle management preferred
Strong technical writing, data analysis, problem-solving, and organizational skills
Excellent communication and teamwork
GMP experience (required)

Nice To Haves

Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred
Bioburden testing
Endotoxin / biotoxin
Environmental Monitoring
Aseptic technique
Microbiology
some chemistry experience would be ideal
LIMS experience is preferred

Responsibilities

Perform routine/non-routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in-process samples, product release, and stability studies following SOPs
Support weekend lab operations and maintain training records
Assist in lab equipment and inventory maintenance, including reagent and sample prep
Review data timely and qualify as a data reviewer
Perform operational assignments (raw material processes, environmental monitoring, in-process testing)
Contribute to updating controlled documents (SOPs, work instructions, test methods)
Follow internal policies, SOPs, and regulatory standards (GMP, GLP, ICH)
Participate in continuous improvement initiatives and cross-functional collaboration
Support regulatory submissions, inspection readiness, and audits