Quality Control Principal Analyst

Makro Scientific; Framingham (MA); On-site; USD 65,000 - 85,000; Full time

Job summary

Makro Scientific in Framingham, Massachusetts, is seeking a qualified candidate for a Quality Control position focused on performing complex laboratory techniques. The role involves using sophisticated analytical methods and leading laboratory projects to improve quality control processes.

The successful applicant will demonstrate strong technical skills and work independently in compliance with regulatory standards while mentoring junior staff. A Bachelor's or Master's degree in life sciences with relevant lab experience is required.

Qualifications

• 6+ years of experience in a cGMP lab environment for Bachelor's applicants.
• 4+ years of experience in a cGMP lab environment for Master's applicants.
• Proficient in laboratory data management systems.
• Ability to present technical data effectively.
• Familiarity with USP and global compendia regulations.

Responsibilities

• Perform UV-Vis spectrophotometry assays and HPLC/GC methods.
• Investigate and troubleshoot Quality Control methods.
• Prepare statistical analysis related to QC results.
• Train less experienced staff on new procedures.
• Implement new technologies and instrumentation.

Skills

Dionex

GC

HPLC

Gel electrophoresis

UV-Vis spectroscopy

Wet chemistry

Empower software

MS Office

Education

Bachelor's Degree in life sciences

Master's Degree in life sciences

Job description

Job Description

Position Summary

This position is responsible for performing routine and complex techniques associated with daily QC release and provides investigative and technological orientation in implementing, executing and interpreting quality procedures and test methods. The successful candidate will substantially contribute to process and method improvements within the Quality Control laboratory.

Core Responsibilities

• Perform UV-Vis spectrophotometry assays, LCS, HPLC/GC/SDS‑PAGE methods for in-process and final product samples.
• Perform maintenance on complex laboratory equipment including HPLC and GC systems.
• Investigate and troubleshoot Quality Control methods.
• Review QC data for compliance with procedures and specifications.
• Prepare statistical analysis of results and investigations related to 005/00T results.
• Participate in training of less experienced staff on new procedures.
• Transfer methods from support groups to the QC laboratory.
• Formulate solutions to laboratory issues through testing of hypotheses.
• Develop and author complex documentation for new and current procedures and technical reports.
• Implement new technologies and instrumentation in the QC laboratory.
• Assume a leadership role in the QC laboratory.
• Provide technical leadership and guidance for major laboratory projects, including implementation of new quality control procedures and transfer of new methods.
• Identify deviations from QC methods and develop appropriate CAPAs.
• Recommend method improvements.
• Contribute to the interpretation of results and impact on products and methods.
• Represent QC as the primary technical contact for laboratory projects.
• Work effectively with others to achieve shared goals and meet timelines.
• Interact with internal and external personnel on technical matters requiring coordination between sites.
• Work independently with minimal to no supervision.
• Operate in compliance with cGMPs.

Qualifications

• Experience with Dionex, GC, HPLC, gel electrophoresis, UV‑Vis spectroscopy and wet chemistry.
• Experience with Empower software.
• Bachelor’s Degree in life sciences and at least 6 years of experience in a cGMP lab environment, or Master’s Degree in life sciences and at least 4 years of experience in a cGMP lab environment.
• Proficient in MS Office and laboratory data management systems.
• Ability to present technical data.
• Ability to work independently on scientific projects.
• Familiarity with USP and global compendia regulations.
• Scientific technical writing ability, including authoring and revising SOPs and technical reports.
• Experience troubleshooting assay and equipment issues.

EEO Statement

All your information will be kept confidential according to EEO guidelines.