Quality Control Analyst II - Microbiology

Quality Control Analyst II•Microbiology at TalentBurst, an Inc 5000 company Quality Control Analyst II•Microbiology at TalentBurst, an Inc 5000 company in Norton, Massachusetts Posted in 8 days ago.

Type:

full-time

Job Description:

Industry:

Pharmaceutical Title:

Quality Control Analyst II•

Microbiology Job ID:

NORT000031

Location:

Norton, MA•02766

Duration:

07 months contract (+Possibility of extension)

WEEKEND SHIFT

•Fri to Mon, 4x10•8 hour shift 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. This is an onsite role in Norton, MA, with occasional responsibilities at other locations. Weekend coverage is required. First shift, Friday-Monday (4 x 10 hours), with initial Monday-Friday training. 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