Title: Quality Control Analyst
Location: Lexington, MA 02421( onsite)
Duration: 6+ Months (Possible Extension)
Position Overview
We are seeking a Quality Control Analyst to support the daily operations of the QC Raw Materials department. This team is responsible for the testing and release of raw materials for GMP use in manufacturing.
The Quality Control Analyst will primarily support laboratory experiments, instrument/method-related projects, and documentation activities. The role will involve working under the guidance of the Lab Manager and experienced QC staff while ensuring all activities are performed in compliance with GMP, regulatory requirements, and established quality control practices.
Key Responsibilities
Execute laboratory experiments, testing, and procedures as directed by the Lab Manager and QC staff.
Support instrument and analytical method-related projects with appropriate supervision.
Participate in project meetings and collaborate with laboratory team members as needed.
Assist with the authoring, revision, and approval of protocols, test methods, SOPs, and validation documentation.
Review and update laboratory documents to ensure accuracy, compliance, and alignment with current QC practices.
Support routine laboratory activities and daily operations within the QC Raw Materials department.
Follow established GMP procedures, laboratory safety requirements, and quality standards.
Maintain accurate and complete laboratory records and documentation.
Work collaboratively with cross-functional team members to support project and laboratory objectives.
Responsibilities / Time Allocation
75% – Laboratory Activities: Execute experiments, procedures, and other laboratory activities as assigned by the Lab Manager and QC staff.
25% – Documentation: Author, revise, review, and maintain procedures, protocols, test methods, SOPs, and validation-related documentation.
Required Qualifications
Bachelor’s degree or higher in Chemistry, Biology, Biochemistry, or a closely related scientific field.
Strong understanding of laboratory practices and ability to follow established procedures.
Ability to work effectively in a regulated laboratory environment.
Strong written and verbal communication skills.
Strong attention to detail and documentation skills.
Preferred Qualifications
Previous experience working in a laboratory environment, preferably within a GMP or pharmaceutical/biopharmaceutical setting.
Experience with Matlab or other chemometric software.
Experience with QC testing, analytical methods, raw materials, or laboratory documentation is a plus.
Familiarity with SOPs, protocols, validation documentation, and GMP practices is preferred.
Work Environment
100% onsite
Hands-on laboratory and documentation responsibilities
Collaboration with Lab Managers, QC staff, and project teams
Role requires the ability to work in a regulated laboratory environment and follow established safety and quality procedures.
Ideal Candidate: A laboratory-focused Chemistry, Biology, or Biochemistry professional who is comfortable performing hands-on experiments while also supporting technical documentation, SOP revisions, analytical method/instrument projects, and GMP quality control activities.
Benefits:
We offer a competitive compensation package that includes:
• [Pay Rate]: $32 - $36 per Hour
o Note: Pay rate will be commensurate with experience.
• Medical for full time employees
• Dental, and Vision Insurance
• Life Insurance, Short-Term Disability, Long-Term Disability, etc.