Tech Ops and Quality - Quality Control Analyst I

TalentBurst, an Inc 5000 company; Norton (MA); On-site; USD 60,000 - 75,000; Full time

Job summary

TalentBurst is seeking a Quality Control Operations Analyst I for a 12-month onsite assignment in Norton, MA, with occasional duties in Cambridge, MA. The role emphasizes executing analytical assays, generating accurate data, and supporting QC operations to ensure product quality from development through commercialization.

The analyst will perform routine and non-routine tests under SOPs, maintain training records, assist with equipment and reagent prep, document observations, and contribute to

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field
• Strong documentation skills and attention to detail are essential
• Effective communication and teamwork are important for cross-functional collaboration
• Familiarity with GMP/GLP regulatory expectations is desirable
• Experience with SOPs and record-keeping supports quality control goals

Responsibilities

• Perform routine and non-routine analytical assays to support raw materials, in-process samples, product release, and stability studies under supervision, following established SOPs
• Maintain up-to-date training records, adhere to the testing schedule, and ensure timely completion of assignments to support QC operations
• Assist in maintenance of laboratory equipment and inventory, and prepare reagents and samples
• Accurately record data and observations in compliance with GxP standards; participate in data review as appropriate
• Contribute to revision and updating of controlled documents, SOPs, and test methods
• Adhere to GMP, GLP, ICH guidelines and internal standards to ensure quality and compliance
• Participate in continuous improvement efforts and collaborate with QC and cross-functional teams
• Pursue ongoing training to deepen QC analytical techniques and regulatory knowledge

Skills

Documentation skills

Attention to detail

Communication

Teamwork

GMP/GLP knowledge

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field

Job description

Title: Quality Control Operations Analyst I
Duration: 12 months
Location: Norton MA

• This position is onsite and will be primarily located in Norton, MA.
• There may occasional responsibilities at a secondary location in Cambridge,MA.

Overview

• The Analyst I in Quality Control Operations will play a critical role in executing assays, generating accurate and reliable data, and supporting the general operations of the laboratory to ensure the quality and compliance of our products from development through to commercialization.

Key Responsibilities:

• Perform routine and non-routine analytical assays to support raw materials, in-process samples, product release, and stability studies under supervision, following established SOPs
• Maintain up-to-date training records, adhere to the testing schedule, and ensure the timely completion of all assignments to support the seamless operation of QC activities and uphold the department's commitment to meeting project timelines and quality metrics
• Assist in the maintenance of laboratory equipment and inventory, including the preparation of reagents and samples to ensure smooth laboratory operations
• Accurately record experimental data and observations in compliance with GxP standards. Participate in the review of data commensurate with experience.
• Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to ensure continuous improvement and compliance with current industry standards and regulatory requirements
• Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.
• Actively participate in continuous improvement efforts by identifying and suggesting enhancements to methods and laboratory processes, particularly those related to efficiency and reliability.
• Collaborate with QC and cross-functional teams to ensure seamless quality control operations and to support the collective goals
• Pursue ongoing training and development to deepen expertise in QC analytical techniques and regulatory compliance.

Qualifications

• Bachelor\'s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field
• 0 to 2 years of experience in a GMP/GLP regulated laboratory environment, with exposure to pharmaceutical or biotechnology industries preferred
• Understanding of analytical techniques and their application in raw materials, in-process testing, release, and stability studies is preferred
• Strong documentation skills and attention to detail, with an unwavering commitment to quality and compliance
• Basic awareness of regulatory guidelines relevant to pharmaceutical QC (GMP, GLP, ICH) is desirable
• Effective communication and teamwork skills, with the ability to work collaboratively across functions
• Capable of working under supervision and following detailed instructions

Why TalentBurst?

At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.