Quality Control Analyst II - Microbiologist

Job Description

Job DescriptionJob Title: Quality Control Analyst II - Microbiologist
Location: Norton, MA 02766
Duration: 9 months+ (Possible Extension)

Pay Range - $40 - $45/hr. on w2

First shift, Friday - Monday (4 x 10 hours), with initial Monday-Friday training. (Weekend shift)

Summary:

• This is an on-site role in Norton, MA, with occasional responsibilities at other client locations. Weekend coverage is required. First shift, Friday-Monday (4 x 10 hours), with initial Monday-Friday training.
• 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. First shift, Friday-Monday (4 x 10 hours), with initial Monday-Friday training.

Key Responsibilities:

• Looking for someone with Microbiology background with hands-on experience in Bioburden and Endotoxin testing , Toc and aseptic techniques.
• 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.

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