Tech Ops and Quality - Quality Control Analyst II

Creative Solutions Services, LLC; Norton (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Quality Control Analyst II onsite in Norton, MA for a 12-month contract to support QC operations from development through commercialization.

The role involves routine and non-routine testing (HPLC/UPLC, microbiology), data trending, investigations, method transfers, and regulatory support. Weekend coverage is required with a 4x10 Friday–Monday schedule and training periods.

Qualifications

• BS 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.

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

Skills

Analytical thinking

Data analysis

Technical writing

Communication

Teamwork

Problem solving

Organizational skills

Education

BS in chemistry, biology, biochemistry, or related field

Tools

LabWare LIMS

Excel

Word

PowerPoint

Job description

Title: Quality Control Analyst II

Job ID: NORT000042

Location: Norton, MA

Duration: 12 months contract ( Possibility of extension)

Shifts & Schedule

Weekend / Weeknight team:

• Fri–Mon, 4x10 schedule
• Target start time 8:00 AM (30-minute flexibility)

This is an onsite 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.

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

Ideal skills and experience:

• Bioburden testing
• Endotoxin / biotoxin
• Environmental Monitoring
• Aseptic technique
• GMP experience (required)
• Microbiology some chemistry experience would be ideal
• LIMS experience is preferred