Sr. Quality Control Specialist

About the Role

We are seeking a highly motivated and detail-oriented Quality Control (QC) Specialist to join a growing laboratory team within a GMP-regulated pharmaceutical/biopharmaceutical environment. This position offers the opportunity to work with advanced laboratory techniques while ensuring the quality, safety, and integrity of life-changing products.

The ideal candidate will have hands-on laboratory experience, a strong understanding of GMP regulations, and a passion for maintaining the highest quality standards in a fast-paced, collaborative environment.

Duration: 6 - 12 months

Shifts:

Wednesday - Saturday (9:30 PM - 8:00 AM)

Location: Boston Massachusetts

Employment Type: Contract

• Perform quality control testing using a variety of laboratory techniques, including:
  • Flow Cytometry
  • Cell Culture
  • Cell Counting
  • Sterility Testing (BACT)
  • Endotoxin Testing (LAL)
  • Visual Inspection
• Accurately record and review laboratory data in accordance with cGMP and Good Documentation Practices (GDP).
• Perform technical review of raw analytical data and ensure data integrity.
• Maintain laboratory records in both paper-based and electronic systems, including LIMS/Electronic Lab Notebook (ELN).
• Conduct routine laboratory and equipment maintenance, calibration, and cleanliness activities.
• Troubleshoot laboratory methods and support investigations related to deviations, out-of-specification (OOS) results, and other quality events.
• Collaborate with cross-functional teams to ensure compliance with quality standards and regulatory requirements.
• Follow Standard Operating Procedures (SOPs), safety guidelines, and regulatory requirements while maintaining a high level of accuracy and attention to detail.

• Bachelor's degree in Biology, Biochemistry, Biotechnology, Microbiology, Molecular Biology, Cell Biology, Immunology, or a related scientific discipline.
• Experience in a GMP pharmaceutical or biopharmaceutical laboratory environment.
• Hands-on experience with multiple laboratory methodologies such as Flow Cytometry, Cell Culture, Cell Counting, Sterility Testing, Endotoxin Testing (LAL), and Visual Inspection.
• Working knowledge of cGMP, Good Documentation Practices (GDP), and laboratory compliance requirements.
• Experience using Laboratory Information Management Systems (LIMS) or Electronic Lab Notebooks (ELN).
• Strong analytical, organizational, and documentation skills.
• Excellent attention to detail and ability to work independently as well as within a collaborative team environment.

• Experience supporting biologics, cell therapy, gene therapy, vaccine, or other advanced pharmaceutical manufacturing programs.
• Experience participating in Deviation, OOS, CAPA, or Root Cause Investigations.
• Strong troubleshooting and problem-solving abilities.
• Familiarity with FDA-regulated laboratory environments.

• Work in a cutting-edge pharmaceutical and biotechnology laboratory.
• Gain exposure to advanced analytical techniques and quality systems.
• Be part of a collaborative team dedicated to improving patient outcomes through high-quality science.
• Opportunity for professional growth and career advancement within a regulated laboratory environment.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.