Quality Control Analyst II

CONTRACT: 10-month extendable

MUST HAVES:

• 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

Job Overview:

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.

Key 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

Qualifications

• 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 Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred