GMP QC Analyst - Contract - Norton, MA
Proclinical is on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.
Primary Responsibilities:
This position is require to support analytical testing and quality control activities within a regulated laboratory environment. This role involves performing routine and non-routine assays, maintaining compliance with industry standards, and contributing to the continuous improvement of laboratory processes.
Skills & Requirements:
- Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
- Familiarity with GMP/GLP-regulated laboratory environments, preferably within pharmaceutical or biotechnology industries.
- Understanding of analytical techniques used in raw material testing, in-process testing, and stability studies is advantageous.
- Strong documentation skills with attention to detail and a commitment to quality and compliance.
- Basic knowledge of regulatory guidelines relevant to pharmaceutical quality control (e.g., GMP, GLP, ICH) is desirable.
The GMP QC Analyst's responsibilities will be:
- Conduct analytical assays for raw materials, in-process samples, product release, and stability studies following established procedures.
- Maintain training records, adhere to testing schedules, and ensure timely completion of assignments to meet project timelines and quality standards.
- Assist in laboratory operations, including equipment maintenance, inventory management, and preparation of reagents and samples.
- Accurately document experimental data and observations in compliance with GxP standards.
- Participate in data review and contribute to updating controlled documents such as SOPs, work instructions, and test methods.
- Ensure adherence to internal policies, SOPs, and regulatory standards (e.g., GMP, GLP, ICH guidelines).
- Identify and suggest improvements to laboratory methods and processes to enhance efficiency and reliability.
- Collaborate with cross-functional teams to support seamless quality control operations.
- Pursue ongoing training to deepen expertise in analytical techniques and regulatory compliance.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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